FDA (Devices) recall action 93800

MEDLINE INDUSTRIES, LP - Northfield recalled 49 products on 2024-03-06

The FDA (Devices) publishes a recall like this one as 49 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 49 pages.

Products: 49
Announced: 2024-03-06
Critical: 6
Units: 6,267,711

Why these products were recalled

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

26–49 of 49

CriticalFDA (Devices)··2024-03-06
Medline Medical Kits Recalled Due to Potential Lack of Sterility
Medline is recalling approximately 3,900 medical device kits and trays nationwide due to potential sterility failures in irrigating solution components. The affected products may not be sterile, creating a risk of infection.
Product
Medline Kits, trays, and packs labeled as follows: a) PORT ACCESS TRAY, REF DYNDA2863; b) PORT ACCESS TRAY, REF DYNDA2863H; c) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518; d) ULTRASOUND GUIDED IV START KIT, REF DYNDV2518H; e) KIT ULTRASOUND PIV START, REF DYNDV2445;
Category
Distribution
1 state
CriticalFDA (Devices)··2024-03-06
Surgical kits and trays recalled due to lack of sterility
Medline Industries is recalling over 3,200 surgical kits and trays containing components that may lack sterility. The recalled products could pose infection risk to patients if used during surgical procedures.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ASC GENERAL MINOR CDS, REF CDS983673G; b) ASC GENERAL MINOR CDS, REF CDS983673I; c) C NURSE BAG KIT, REF DYKM1425; d) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; e) GASTRIC CULTURE PACK, REF DYNJ53966A; f) GASTRI
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medical device kits recalled due to potential sterility failure
Medline Industries is recalling IV securement kits and neonatal PICC line insertion trays due to potential lack of sterility in Nurse Assist components. Approximately 11,812 units are affected.
Product
Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) SECONDARY IV START KIT, REF IV8695A
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline kits and trays recalled for potential lack of sterility
Medline Industries is recalling surgical kits and trays containing irrigation solutions that may not be sterile due to manufacturing issues. The non-sterile solutions could increase infection risk during surgical and obstetrical procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Port Removal Kits Recalled for Potential Sterility Loss
Medline Industries recalls certain port removal kits due to potential loss of sterility in irrigation solutions manufactured using specific component lots.
Product
Medline Kits, trays, and packs labeled as follows: a) PORT REMOVAL PACK, REF DYNDA2936; b) PORT REMOVAL PACK, REF DYNDA2936H
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Catheterization Kits Recalled for Potential Sterility Defect
Medline Industries is recalling catheterization kits for potential sterility defects in component irrigation solutions. Non-sterile solutions used in medical procedures could result in serious infections.
Product
MEDLINE Kits, trays, and packs labeled as follows: CATHETERIZATION KIT, REF DYNDA2939
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Surgical Kits Recalled for Potential Lack of Sterility
Medline Industries recalls multiple surgical and central line kits containing Nurse Assist components that may lack sterility. Approximately 86,699 units of these medical device kits have been distributed nationwide.
Product
Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY, REF CVI4705; b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700; c) DRESSING CHANGE TRAY, REF DYNDC3131A; d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A; e) DRSG CHANGE TRAY W/ CHG, REF DT21460B; f)
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Surgical Kits Recalled for Potential Sterility Defects
Medline is recalling surgical kits and trays with components that may lack sterility. The affected products were distributed nationwide and internationally.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF DYNJ4
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Medical Kits and Trays Recalled for Non-Sterile Solutions
Medline Industries is recalling multiple medical kits and trays containing irrigation solutions that may be non-sterile. The affected products are used in surgical and invasive procedures; non-sterile solutions could cause serious infections.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK,
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medical maintenance flush kits recalled for potential sterility defect
Medline Industries is recalling Centurion maintenance flush and blood draw kits due to potential sterility issues in component solutions. Affected lot numbers are 2022031480 and 2022041180.
Product
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Blood Draw and Lab Collection Kits Recalled for Potential Sterility Defect
Medline Industries is recalling blood draw and lab collection kits due to potential lack of sterility in component solutions. The affected kits could contain non-sterile solutions, posing risks in clinical procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Surgical Kits Recalled for Potential Sterility Failure
Medline Industries recalls surgical kits and trays manufactured with non-sterile solutions due to contaminated Nurse Assist components. Kits distributed nationwide and internationally may lack proper sterility, posing infection risk.
Product
Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ68875F; c) CATARACT PACK, REF DYNJ54869F; d) CATARACT PREP PACK, REF DYNJ44917L; e) E-BLEPH CDS, REF CDS983585G; f) EYE CDS, REF CDS983916G; g) EYE KIT,
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline surgical kits and trays recalled for sterility defects
Medline Industries recalls 5,969 surgical kits and trays that may lack sterility due to components from Nurse Assist. The non-sterile irrigation solutions could compromise product safety.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) C-SECTION, REF DYNJ904653G; b) DRESSING TRAY, REF M101426; c) ENDO KIT, REF DYKE1387; d) ENDO KIT, REF DYKE1364B; e) ENDO KIT, REF DYKE1892; f) ENDO KIT W/ BLUE TOTE BAG, REF DYKE1648I; g) EYE KIT, REF DYKM2222;
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Medical Kits and Trays Recalled for Potential Sterility Failure
Medline Industries is recalling certain sterile medical kits and trays that contain component solutions with a potential lack of sterility. Non-sterile solutions could result in infection or contamination during medical procedures.
Product
Medline Kits, trays, and packs labeled as follows: a) LACERATION KIT, REF SUT13935; b) LACERATION TRAY, REF SUT21215; c) LACERATION TRAY, REF SUT15380; d) LACERATION TRAY W/SNAGFREE NEE, REF SUT19005; e) PLASTICS SUTURE TRAY, REF SUT13535; f) UVC INSERTION TRAY, REF
Category
Distribution
1 state
CriticalFDA (Devices)··2024-03-06
Medline Tracheostomy Care Kits Recalled for Non-Sterile Component Solutions
Medline Industries is recalling care and cleaning kits for tracheostomy and stomas due to component solutions that may not be sterile. The affected kits contain Nurse Assist-manufactured saline and irrigation solutions distributed in the U.S., Puerto Rico, Canada, UAE, and Panama.
Product
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline wound irrigation kits recalled for potential sterility defects
Medline Industries is recalling approximately 2,205 wound irrigation kits due to potential lack of sterility in component solutions. Non-sterile irrigation solutions pose a risk of infection during wound care.
Product
Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Dialysis Kits Recalled for Potential Sterility Defects
Medline Industries is recalling certain dialysis kits and trays due to potential sterility defects in component irrigation solutions and saline products. Non-sterile solutions used in dialysis could cause infection.
Product
MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Irrigation Kits and Packs Recalled for Sterility Defect
Medline Industries recalls 279 irrigation and saline kits, trays, and packs due to potential lack of sterility in components used to manufacture them. Solutions may be non-sterile.
Product
Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&C PACK, REF DYNJ67214G
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Centurion maintenance flush kits recalled for sterility failure
Medline Industries is recalling Centurion maintenance flush and blood draw kits that may lack sterility due to defective components, potentially allowing infections during medical procedures.
Product
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Surgical Kits and Trays Recalled Due to Potential Sterility Defect
Medline Industries is recalling surgical kits and trays that may contain non-sterile irrigation solutions. Affected products were manufactured with certain component lots that have a potential sterility defect.
Product
Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1629; c) CVL INSERTION KIT-LF, REF DYNJ48587A; d) EXTREMITY CDS, REF CDS983313I; e) EXTREMITY CDS, REF DYNJ902004D; f) EXTREMITY CDS, REF DYNJ902004F;
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Centurion surgical trays and kits recalled for potential non-sterile solutions
Medline Industries is recalling 14,234 units of Centurion surgical kits and trays that may contain non-sterile irrigation solutions. The affected products were manufactured using compromised Nurse Assist components.
Product
Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE MGMT KIT, REF DM640A; c) CIRCUMCISION TRAY, REF CIT6180; d) INCISION & DRAINAGE TRAY, REF ID1690; e) LACERATION TRAY, REF SUT19510; f) LACERATION TRAY,
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Medical Kits and Trays Recalled for Potential Sterility Failure
Medline Industries is recalling certain medical kits and trays that may contain non-sterile solutions. Healthcare facilities should discontinue use of affected batches to prevent patient exposure to potential contamination.
Product
MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B; c) PK, RADIOLOGY, REF DYNJ44087A; d) PORT ACCESS PACK-LF, REF DYNJ0352159C; DYNJ0352159D
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Bronchoscopy Tray Components Recalled for Potential Lack of Sterility
Medline Industries is recalling certain Nurse Assist components used in Bronchoscopy Trays due to potential lack of sterility. Affected irrigation solutions and saline flush syringes may be non-sterile.
Product
MEDLINE BRONCHOSCOPY TRAY, REF DYNDL1350A
Category
Distribution
1 state
SevereFDA (Devices)··2024-03-06
Medline Surgical Kits Recalled for Potential Lack of Sterility
Medline Industries is recalling 139 surgical kits containing irrigation solutions with potential sterility issues. The recalled products were distributed nationwide and internationally.
Product
Medline Kits, trays, and packs labeled as follows: a) BREAST PACK, REF DYNJ56344B; b) SEPTOPLASTY PACK WRO-LF, REF DYNJ62803
Category
Distribution
1 state