April 2016 recalls

764 recalls were announced in April 2016.

What the numbers show

Critical: 20
Severe: 108
High: 373
Moderate: 207
Low: 56

Of the 764 recalls this month scored against our rubric, 3% are Critical, 14% are Severe.

Which agencies issued them

201–300 of 764

HighFDA (Devices)·Z-1380-2016·2016-04-20
Philips EPIQ Ultrasound Systems Recalled for Control Panel Fastener Loosening
Philips is recalling EPIQ diagnostic ultrasound systems because fasteners securing the control panel may loosen, potentially causing the assembly to detach.
Product
EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonata
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1493-2016·2016-04-20
Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 25 arthroscopy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1450-2016·2016-04-20
Customed Minor Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 344 Minor Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1480-2016·2016-04-20
Customed Utility Drapes Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 800 units of Utility Drapes with Tape, SMS, due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900582 UTILITY DRAPE WITH TAPE, SMS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1431-2016·2016-04-20
Customed Femoral Surgical Pack Recall for Sterilization Validation Issues
Customed, Inc. is recalling 55 femoral surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1371-2016·2016-04-20
Maquet QUADROX-i oxygenators recalled for potential endotoxin exposure
Maquet Cardiovascular is voluntarily recalling QUADROX-i oxygenators and tubing packs due to a potential risk of endotoxin exposure.
Product
QUADROX-i oxygenators Custom tubing packs for the oxygenator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2016·2016-04-20
Customed Laparoscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 120 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900474 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1485-2016·2016-04-20
Customed Ortho-Implant Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 153 Ortho-Implant Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900741A ORTHO-IMPLANT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1398-2016·2016-04-20
Customed Suture Removal Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 9,000 Suture Removal Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1424-2016·2016-04-20
Customed Wound Management Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 200 Wound Management Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1488-2016·2016-04-20
Customed sterile skin staple remover recalled for sterilization validation issues
Customed, Inc. is recalling 580 sterile skin staple removers distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1372-2016·2016-04-20
Maquet Recalls HLS Set Advanced Oxygenator Tubing Packs Due to Endotoxin Risk
Maquet Cardiovascular is voluntarily recalling HLS Set Advanced oxygenator tubing packs due to a potential risk of exposure to endotoxin.
Product
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1459-2016·2016-04-20
Customed Urethral Catheter Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,450 Urethral Catheter Trays (14FR) distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900278 URETHRAL CATHETER TRAY 14FR Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1421-2016·2016-04-20
Customed Neuro-Spine Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 81 Neuro-Spine Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1483-2016·2016-04-20
Customed Fan Fold Sheets Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,920 fan fold sheets distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1366-2016·2016-04-20
ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues
ICU Medical is recalling 3 units of the Diana Automated Compounding System because compounded volumes under 5ml may not meet accuracy specifications.
Product
Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1494-2016·2016-04-20
Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 111 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1486-2016·2016-04-20
Customed Carpal Tunnel Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 162 carpal tunnel surgical packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
Catalog Number: 900742A CARPAL TUNEL LARGE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1469-2016·2016-04-20
Customed Labor and Delivery Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 44 Labor and Delivery Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900419 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1369-2016·2016-04-20
ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues
ICU Medical is recalling 49 units of the Diana Automated Compounding System because it may not meet accuracy specifications when mixing volumes under 5ml.
Product
Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1404-2016·2016-04-20
Customed Minor Procedure Surgical Packs Recalled for Sterilization Defects
Customed, Inc. is recalling 40 units of Minor Procedure Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1406-2016·2016-04-20
Customed Wound Closure Tray II Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 600 units of Wound Closure Tray II in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1466-2016·2016-04-20
Customed Basic Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 55 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1381-2016·2016-04-20
GE Healthcare Recalls Aisys CS2 Anesthesia Devices Due to Bolus Issue
GE Healthcare is recalling Aisys CS2 and upgraded Aisys anesthesia devices due to a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen.
Product
GE Healthcare, Aisys CS2 anesthesia..
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1447-2016·2016-04-20
Customed Laparoscopy-Colorectal Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 84 laparoscopy-colorectal surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1445-2016·2016-04-20
Customed Surgical Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 280 surgical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1405-2016·2016-04-20
Customed Wound Closure Tray I Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Wound Closure Tray I units due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1437-2016·2016-04-20
Customed Recalls Sterile Mayo Stand Covers Due to Sterilization Validation Issues
Customed, Inc. is recalling 540 sterile Mayo stand covers distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1385-2016·2016-04-20
Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risk
Synthes (USA) Products LLC is recalling 289 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if a surgeon attempts to remove it.
Product
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1478-2016·2016-04-20
Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 150 Pery-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1402-2016·2016-04-20
Customed Universal Drainage Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 900 Universal Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1477-2016·2016-04-20
Customed Basic Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 10 Basic Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900547 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1484-2016·2016-04-20
Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 108 Arthroscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1425-2016·2016-04-20
Customed REYITO PLUS Urology Surgical Pack Recalled for Sterilization Defects
Customed, Inc. is recalling 35 units of REYITO PLUS Urology Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighCPSC·16149·2016-04-20
YTL International Recalls Drywall Lifts Due to Injury Hazard
YTL International is recalling about 17,000 drywall lifts because they can fail and drop loads, posing an injury risk. No injuries have been reported.
Product
Drywall lifts
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1416-2016·2016-04-20
Customed Laminectomy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 42 Laminectomy Packs due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Product
Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1377-2016·2016-04-20
Intuitive Surgical Recalls da Vinci S Surgical System User Manuals
Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using non-approved instruments with ablation probes may increase microscopic metallic particulates.
Product
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments inclu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0824-2016·2016-04-20
Morrison Milling Recalls HEB Fish Fry Mix Due to Metal Fragments
Morrison Milling is recalling HEB Original Seasonal Fish Fry Mix because it may contain small metal fragments from a wire mesh sifter.
Product
HEB Original Seasonal Fish Fry Mix NET WT. 16 OZ (1 LB) CONT. NET 454g and HEB Original Seasonal Fish Fry Mix NET WT. 10 OZ CONT. NET 284g packed in paper box
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1451-2016·2016-04-20
Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 76 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1457-2016·2016-04-20
Customed Shoulder Packs Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 39 sterile shoulder packs used for surgical and patient care procedures due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1455-2016·2016-04-20
Customed Open Heart Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 47 Open Heart Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1399-2016·2016-04-20
Customed OB Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 32 OB Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1473-2016·2016-04-20
Customed Laparoscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 60 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1446-2016·2016-04-20
Customed Neurosurgery Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 24 neurosurgery packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1443-2016·2016-04-20
Customed Lithotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 150 Lithotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1409-2016·2016-04-20
Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 16 Arthroscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1448-2016·2016-04-20
Customed Basic Surgical Pack IV Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 30 units of Basic Surgical Pack IV in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1442-2016·2016-04-20
Customed Femoral Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 24 femoral surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1407-2016·2016-04-20
Customed Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 140 Cystoscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighNHTSA·16V228000·2016-04-20
Toyota 4Runner Recall for Inaccurate Load Carrying Capacity Label
Gulf States Toyota is recalling 2015-2016 Toyota 4Runners with dealer-installed accessories because the load carrying capacity label may be incorrect, potentially leading to vehicle overload.
Product
TOYOTA — TOYOTA 4RUNNER
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1384-2016·2016-04-20
Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks
Synthes (USA) Products LLC is recalling 200 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.
Product
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1386-2016·2016-04-20
Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks During Removal
Synthes (USA) Products LLC is recalling 378 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures if a surgeon attempts to remove it.
Product
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1438-2016·2016-04-20
Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 168 ophthalmic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1382-2016·2016-04-20
GE Healthcare Recalls Aisys Carestation Anesthesia Devices Due to Bolus Issue
GE Healthcare is recalling Aisys Carestation anesthesia devices due to a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen.
Product
GE Healthcare, Aisys Carestation.
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1465-2016·2016-04-20
Customed Surgical Gowns Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 96 surgical gowns distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9003190 SURG GOWN SMS AMMI IV FULL Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1401-2016·2016-04-20
Customed Laparoscopy Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 60 units of Laparoscopy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1475-2016·2016-04-20
Customed Recalls Surgical Gowns Due to Sterilization Validation Issues
Customed, Inc. is recalling 1,148 surgical gowns distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1456-2016·2016-04-20
Customed Hip and Knee Replacement Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 24 Hip and Knee Replacement Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1335-2016·2016-04-20
Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms
Dexcom Inc is recalling 18,004 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.
Product
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with d
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1373-2016·2016-04-20
Maquet Rotaflow Centrifugal Pump Tubing Recalled for Endotoxin Risk
Maquet Cardiovascular is voluntarily recalling Rotaflow Centrifugal Pump custom tubing packs due to a potential risk of endotoxin exposure.
Product
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1360-2016·2016-04-20
Arthrex Deltoid Ligament Implant Recalled for Potential Sterility Issue
Arthrex is recalling 117 Deltoid Ligament Reconstruction Implant Systems because a component may not be sterile.
Product
Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1400-2016·2016-04-20
Customed Irrigation Trays Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 4,400 irrigation trays with bulb syringes distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1403-2016·2016-04-20
Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 132 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1334-2016·2016-04-20
Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms
Dexcom Inc is recalling G4 PLATINUM Receivers because they may fail to provide intended audible alarms or alerts to users.
Product
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1368-2016·2016-04-20
ICU Medical Recalls Diana Automated Compounding Systems Due to Volume Accuracy Issues
ICU Medical is recalling 47 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.
Product
Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1060-2016·2016-04-20
Stratas Foods Recalls Silver Source Creamy Fry Oil Due to Plastic Contamination
Stratas Foods is recalling 840 cases of Silver Source Creamy Fry Oil because a supplier reported that a piece of plastic from a container neck finish may be present in the product.
Product
Silver Source Creamy Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 0 08 06795 02236 0
Category
Food
Distribution
3 states
HighFDA (Food)·F-1061-2016·2016-04-20
Stratas Foods Recalls Canola Salad Oil Due to Potential Plastic Contamination
Stratas Foods is recalling 218 cases of Silver Source Canola Salad Oil because a supplier reported that pieces of plastic from container necks may be present in the product.
Product
Silver Source Canola Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 0 08 06795 42770 7
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1439-2016·2016-04-20
Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 168 ophthalmic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001933 OPHTALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-1062-2016·2016-04-20
Stratas Foods Recalls Silver Source Canola Fry Oil Due to Plastic Contamination
Stratas Foods is recalling 540 cases of Silver Source Clear Canola Fry Oil because a supplier reported that pieces of plastic from container necks may be present in the product.
Product
Silver Source Clear Canola Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 0 08 06795 02237 7
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1454-2016·2016-04-20
Customed Extremity Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 136 Extremity Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1418-2016·2016-04-20
Customed Premium Laparotomy Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 258 Premium Laparotomy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1490-2016·2016-04-20
Customed C-Section Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 238 C-Section Surgical Packs because the sterilization processes and package integrity were not adequately validated.
Product
Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1440-2016·2016-04-20
Customed Liver and Pancreas Surgery Kits Recalled for Sterilization Issues
Customed, Inc. is recalling 20 liver and pancreas surgery kits due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-1065-2016·2016-04-20
Chicken of the Sea Recalls Canned Light Tuna Due to Undercooking Risk
Tri-Union Seafoods is voluntarily recalling specific lots of Chicken of the Sea canned light tuna because an equipment malfunction may have resulted in undercooked product.
Product
Chicken of the Sea 5 Oz. Canned Chunk Light Tuna in Water, 48 cans per case, UPC code is 0 4800000245 7
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1429-2016·2016-04-20
Customed Dressing Change Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 550 Dressing Change Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-1064-2016·2016-04-20
Chicken of the Sea Canned Tuna Recalled for Potential Undercooking
Tri-Union Seafoods is recalling Chicken of the Sea canned tuna due to an equipment malfunction that may have caused the product to be undercooked.
Product
Chicken of the Sea 5 Oz. Canned Chunk Light Tuna in Oil, 48 cans per case, UPC code is 0 4800000195 5
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1423-2016·2016-04-20
Customed Recalls Umbilical Vessel Catheter Kits Due to Sterilization Concerns
Customed, Inc. is recalling 40 umbilical vessel catheter kits distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1428-2016·2016-04-20
Customed Urology Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 24 Urology Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1426-2016·2016-04-20
Customed ENT Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 70 ENT Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1411-2016·2016-04-20
Customed Tracheostomy Care Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,800 tracheostomy care kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1496-2016·2016-04-20
Customed Cesarean Section Surgical Packs Recalled for Sterilization Defects
Customed, Inc. is recalling 32 units of Cesarean Section Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900998 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-1063-2016·2016-04-20
Stratas Foods Recalls Silver Source Clear Fry Oil Due to Plastic Contamination
Stratas Foods is recalling Silver Source Clear Fry Oil because a supplier reported that plastic pieces from container necks may be present in the product.
Product
Silver Source Clear Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by Performance Food Group, Richmond, VA 23238, UPC 008 06795 02237 3
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1492-2016·2016-04-20
Customed Strabismus Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling eight Strabismus Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900946 STRABISMUS SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1491-2016·2016-04-20
Customed Cataract Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 576 cataract surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1376-2016·2016-04-20
Intuitive Surgical Recalls da Vinci S Surgical System User Manuals
Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using certain instruments with ablation probes can increase microscopic metallic particulates.
Product
da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endosco
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1059-2016·2016-04-20
Burger King Liquid Frying Oil Recalled for Potential Plastic Contamination
Stratas Foods is recalling Burger King Liquid Frying Oil because a supplier reported that pieces of plastic from container necks may be present in the product.
Product
Burger King Liquid Frying Oil, Net Wt. 35 LB (15.9 kg), Miami, Florida 33126, UPC 2 06 75258 06956 3
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-1472-2016·2016-04-20
Customed Laparoscopic Gynecology Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 30 units of Laparoscopic Gynecology Surgical Packs due to inadequate sterilization validation and package integrity concerns.
Product
Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1435-2016·2016-04-20
Customed Laparotomy Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 938 Laparotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1410-2016·2016-04-20
Customed Pery-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 80 Pery-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-0887-2016·2016-04-20
Morrison's Pancake Mix Recalled for Potential Metal Fragments
Morrison's Pancake Mix is being recalled because it may contain small metal fragments from a wire mesh sifter.
Product
Morrison's Pancake Mix Complete Net Wt 5 LB (2.27 kg)
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1489-2016·2016-04-20
Customed Femoral Angiography Surgical Pack Recalled for Sterilization Issues
Customed, Inc. is recalling 16 units of Femoral Angiography Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1462-2016·2016-04-20
Customed Orthopedic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 85 orthopedic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002830 ORTHOPEDIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1419-2016·2016-04-20
Customed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 220 units of Premium Obstetrical Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1413-2016·2016-04-20
Customed Foley Catheter Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 380 units of Foley Catheter Trays in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1470-2016·2016-04-20
Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 110 Laparotomy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900450 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-1046-2016·2016-04-20
Kroger Chicken Salad Croissant Sandwiches Recalled for Undeclared Fish
Mt Perry Foods is recalling Kroger Brand Chicken Salad Croissant Sandwiches sold in Ohio and West Virginia because they contain undeclared fish.
Product
Kroger Brand Chicken Salad Croissant Sandwiches packaged in individual clear rigid plastic clamshell containers packaged in 6 brown corrugated card board boxes, 6 to a case, for a total of 36 sandwiches. Cases identified with white stick on label with black ink printing reading
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-1397-2016·2016-04-20
Customed Recalls Sterile Mayo Stand Covers Due to Sterilization Validation Issues
Customed, Inc. is recalling 540 sterile Mayo stand covers distributed in Puerto Rico because the company could not validate the sterilization process or package integrity.
Product
Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1452-2016·2016-04-20
Customed Arthroscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 18 Arthroscopy Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1460-2016·2016-04-20
Customed Laparotomy Packs Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 597 laparotomy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900281A LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1479-2016·2016-04-20
Customed Lap-Cholecystectomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 144 units of Lap-Cholecystectomy Surgical Packs due to inadequate validation of sterilization processes and package integrity.
Product
Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state

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