The Recall Desk

Archive

March 2017 recalls

854 recalls were announced in March 2017.

What the numbers show

Critical
90
Severe
243
High
356
Moderate
134
Low
31

Of the 854 recalls this month scored against our rubric, 11% are Critical, 28% are Severe.

801–854 of 854

  • HighFDA (Food)·F-1527-2017·2017-03-01

    Falafel King Recalls Tzatziki Sauce for Undeclared Milk Allergen

    Falafel King is recalling 1,380 containers of Tzatziki Sauce due to undeclared milk on the label. The product was distributed in Colorado, New Mexico, Utah, and Nebraska.

    Product
    Falafel King Tzatziki Sauce. 10 ounce. Plastic container
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1170-2017·2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Unicompartmental Knee Phase 3 Shim Size 1 instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1158-2017·2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighNHTSA·17V127000·2017-03-01

    Volvo Recalls 2017 Models for Side Air Bag Inflator Defect

    Volvo is recalling 2017 S60, V60, and XC60 vehicles because side air bag inflators may fail to ignite, preventing deployment in a crash.

    Product
    VOLVO — VOLVO V60CC, S60CC, V60, XC60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2017·2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1154-2017·2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1229-2017·2017-03-01

    Philips Efficia CMS200 Central Monitoring System Recalled for Pediatric Alarm Defect

    Philips is recalling 156 Efficia CMS200 central monitoring systems because they may not alarm appropriately for pediatric or neonatal patients.

    Product
    Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1233-2017·2017-03-01

    Degania Silicone Jackson-Pratt Drain Recalled for Sterility Compromise

    Degania Silicone is recalling 3,040 units of Jackson-Pratt Channel Drain Silicone Round because the sterile barrier was breached, compromising sterility.

    Product
    Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1162-2017·2017-03-01

    Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions

    Biomet is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1160-2017·2017-03-01

    Biomet Oxford Knee Instruments Recalled for Material Inclusions

    Biomet is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighNHTSA·17V129000·2017-03-01

    Forest River Recalls 2017 Rockwood and Flagstaff Trailers for Tire Defect

    Forest River is recalling 2017 Rockwood and Flagstaff recreational trailers because a slide room bracket may damage the front tire, causing deflation and increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER ROCKWOOD, FLAGSTAFF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1166-2017·2017-03-01

    Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1168-2017·2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Unicompartmental Knee Phase 3 Shim Size 3 instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-1514-2017·2017-03-01

    Hostess Recalls Holiday White Peppermint Twinkies Due to Salmonella Risk

    Hostess Brands is recalling Holiday White Peppermint Twinkies because an ingredient may be contaminated with Salmonella. The product was distributed nationwide.

    Product
    Holiday White Peppermint Hostess Twinkies, cream-filled snack cakes, Net Wt. 13.02 oz. (369 g), UPC 888109111571.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2017·2017-03-01

    Biomet Recalls Oxford Partial Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1153-2017·2017-03-01

    Biomet Oxford Knee Instruments Recalled for Potential Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System Femoral Slap Hammers due to potential alumina inclusions that could cause the instruments to crack or separate.

    Product
    Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1171-2017·2017-03-01

    Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1156-2017·2017-03-01

    Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions

    Biomet U.K. is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1175-2017·2017-03-01

    Biomet Oxford Knee Instruments Recalled for Material Inclusions

    Biomet is recalling Oxford Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-1530-2017·2017-03-01

    Mahatma Broccoli and Cheese Rice Recalled for Foreign Metal Material

    Riviana International is recalling Mahatma Broccoli & Cheese Rice due to the potential presence of foreign metal material.

    Product
    Mahatma Broccoli & Cheese Rice; 4 oz. net weight (UPC 17400-10529); packed 12 units in each case (sold as individual retail units). Shelf life is 18 months
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1234-2017·2017-03-01

    Custom Medical Specialties Recalls Biopsy Trays with Syringes Due to Sterility Concerns

    Custom Medical Specialties is recalling 80 biopsy trays containing syringes because the sterility of the syringes could not be assured. The affected products were distributed to Idaho and Oregon.

    Product
    CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1163-2017·2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Drugs)·D-0483-2017·2017-03-01

    Cherry Hill Sales Recalls Hemorrhoidal Cream Due to Manufacturing Deviations

    Cherry Hill Sales Co. is voluntarily recalling 3,600 cartons of MakeSense Hemorrhoidal Relief Cream due to CGMP deviations.

    Product
    MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-205-28
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Food)·F-1479-2017·2017-03-01

    Wegmans Organic Dark Red Kidney Beans Recalled for Damaged Cans

    Hanover Foods is recalling Wegmans Organic Dark Red Kidney Beans because damaged cans could fracture and cause post-process contamination.

    Product
    Wegmans Organic Dark Red Kidney Beans, Net Wt. 15 OZ
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1245-2017·2017-03-01

    Tosoh G8 Reporting Software Recalled Due to Power Outage Shutdowns

    Tosoh Smd Inc is recalling 34 units of Reporting Software for the G8 analyzer because power outages cause the software to shut down.

    Product
    Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2017·2017-03-01

    Sandoz Recalls Transderm Scop Patches Due to Incorrect Labeling Instructions

    Sandoz Inc. is recalling Transderm Scop patches because the outer carton contains incorrect instructions for cutting the patch.

    Product
    Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1250-2017·2017-03-01

    Vascular Solutions Recalls GrebSet Micro-Introducer Kits Due to Shelf Life Discrepancy

    Vascular Solutions is recalling 633 units of GrebSet Micro-Introducer Kits because the guidewires have a shorter shelf life than the kit expiration date.

    Product
    GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1230-2017·2017-03-01

    Cardiovascular Systems Recalls Mislabelled Diamondback 360 Peripheral Atherectomy Components

    Cardiovascular Systems Inc is recalling 8 units of the Diamondback 360 Peripheral 1.50 Classic system because a 1.50mm Solid Crown OAD was mislabeled as a 1.50mm Crown OED.

    Product
    DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0485-2017·2017-03-01

    Cherry Hill Sales Recalls Medicated Anti-Itch Cream Due to CGMP Deviations

    Cherry Hill Sales Co. is voluntarily recalling 4,800 cartons of MakeSense PHARMA Medicated Anti-Itch Cream due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMIN E, Camphor-1% Menthol-1%, 1oz.(28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-201-28
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1249-2017·2017-03-01

    Durex Condoms Recalled for Missing Benzocaine Labeling Information

    Reckitt Benckiser LLC is recalling Durex Pleasure Pack condoms because the package labeling is missing information about the active ingredient Benzocaine.

    Product
    Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2017·2017-03-01

    Smith & Nephew Dyonics Saw Blade Recall for Missing Expiration Date

    Smith & Nephew is recalling 2,646 Dyonics Saw Blades because they are provided sterile but lack an expiration date on the label.

    Product
    Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1244-2017·2017-03-01

    Smith & Nephew Dyonics Saw Blade Recall Due to Missing Expiration Date

    Smith & Nephew is recalling 1,410 Dyonics Saw Blades because the single-use sterile devices lack expiration dates on the label.

    Product
    Smith & Nephew Dyonics Saw Blade, Long, Special, Product Number 3706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1242-2017·2017-03-01

    Smith & Nephew Recalls Dyonics Saw Blades Due to Missing Expiration Dates

    Smith & Nephew is recalling 8,748 Dyonics Saw Blades because the single-use sterile devices lack expiration dates on their labels.

    Product
    Smith & Nephew Dyonics Saw Blade, Short, Narrow, Product Number 3704
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2017·2017-03-01

    Merge Eye Station Import Utility Recalled for Image Import Errors

    Merge Healthcare is recalling the Eye Station Import Utility because images were not importing properly and were imported under "unknown" due to a validation issue.

    Product
    Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0487-2017·2017-03-01

    Cherry Hill Sales Recalls Clotrimazole Antifungal Cream Due to CGMP Deviations

    Cherry Hill Sales Co. is voluntarily recalling 2,400 cartons of MakeSense PHARMA ANTIFUNGAL CREAM due to CGMP deviations. The product was distributed in five states.

    Product
    MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-203-35
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1226-2017·2017-03-01

    BioMerieux ETEST XM256 Cefuroxime Recalled for Potential Performance Issues

    BioMerieux SA is recalling ETEST XM256 (Cefuroxime) antimicrobial susceptibility test strips due to potential performance issues that may result in false susceptibility or intermediate results.

    Product
    ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus…
    Category
    Medical Device
    Distribution
    37 states
  • ModerateFDA (Devices)·Z-1227-2017·2017-03-01

    Siemens N Latex HCY Reagent Recalled for Stability Issues

    Siemens Healthcare Diagnostics is recalling N Latex HCY Reagent kits due to reduced stability that may cause inaccurate homocysteine test results.

    Product
    N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1248-2017·2017-03-01

    DeRoyal Heart Tracecart Recall Due to Sterile Component Packaging Issue

    DeRoyal is recalling Heart Tracecarts because they contain a sterile chest drainage product affected by a packaging configuration issue.

    Product
    SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1231-2017·2017-03-01

    Quidel Recalls Influenza Transport Swab Packages Due to Incorrect Swabs

    Quidel Corporation is recalling Influenza Transport Swab Packages because they may contain incorrect sample swabs mixed with the proper ones.

    Product
    Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1240-2017·2017-03-01

    Smith & Nephew Dyonics Saw Blade Recall for Missing Expiration Date

    Smith & Nephew is recalling Dyonics Saw Blades because they are provided sterile but lack an expiration date on the label.

    Product
    Smith & Nephew Dyonics Saw Blade, Standard, Thick, Product Number 3702
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1243-2017·2017-03-01

    Smith & Nephew Dyonics Saw Blade Recall for Missing Expiration Date

    Smith & Nephew is recalling 3,462 Dyonics Saw Blades, Narrow (Product Number 3705) because the single-use sterile devices lack an expiration date on the label.

    Product
    Smith & Nephew Dyonics Saw Blade, Narrow, Product Number 3705
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1528-2017·2017-03-01

    Nature's Wonderland Sinus & Lung Care Recalled for Ingredient Mix-Up

    Penn Herb Company is recalling Nature's Wonderland Sinus & Lung Care capsules because Ginkgo Leaves were accidentally added to the herbal blend instead of Ginger Root.

    Product
    Nature's Wonderland Sinus & Lung Care, 60 VCaps (Capsules), PET bottle
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1247-2017·2017-03-01

    DeRoyal Heart Tracecart Recall Due to Contained Chest Drainage Product Issue

    DeRoyal Industries is recalling Heart Tracecarts because they contain a Maquet Getinge chest drainage product affected by a separate packaging recall.

    Product
    DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1241-2017·2017-03-01

    Smith & Nephew Recalls Dyonics Saw Blades Due to Missing Expiration Dates

    Smith & Nephew is recalling 4,500 Dyonics Saw Blades, Short (Product Number 3703) because the single-use sterile devices lack expiration dates on their labels.

    Product
    Smith & Nephew Dyonics Saw Blade, Short, Product Number 3703
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2017·2017-03-01

    Cherry Hill Sales Recalls MakeSense Antifungal Cream Due to CGMP Deviations

    Cherry Hill Sales Co. is voluntarily recalling 2,400 cartons of MakeSense PHARMA ANTIFUNGAL CREAM due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-208-28
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0484-2017·2017-03-01

    Cherry Hill Sales Recalls MakeSense First Aid Cream Due to CGMP Deviations

    Cherry Hill Sales Co. is voluntarily recalling 7,200 cartons of MakeSense First Aid Cream due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-210-28
    Category
    Drug
    Distribution
    5 states
  • LowFDA (Drugs)·D-0489-2017·2017-03-01

    Sage Q Care Continue Care Kit Recalled for Incorrect Expiration Date

    Sage Products Inc is recalling 640 Q Care Continue Care Kits because the kit's printed expiration date is incorrect. The kits contain oral care products with an earlier expiration date than printed on the main kit.

    Product
    Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1223-2017·2017-03-01

    Applied Medical Technology Recalls Nasal Tube Retaining Systems Due to Expired Dates

    Applied Medical Technology is recalling 110 units of the AMT Bridle Nasal Tube Retaining System because expired expiration dates are listed on the pouches.

    Product
    AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-1237-2017·2017-03-01

    Hidrex USA DVP1000 Recalled Due to Documentation Requirements

    Hidrex GmbH is recalling 180 units of the Hidrex USA DVP1000 device because it was reclassified from Class III to Class II, triggering new documentation requirements.

    Product
    Hidrex USA DVP1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1224-2017·2017-03-01

    Applied Medical Technology Recalls Expired Feeding Sets

    Applied Medical Technology is recalling 110 units of AMT 12-inch Right Angle Feeding Sets with Y-Ports due to expired expiration dates listed on the pouches.

    Product
    AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
    Category
    Medical Device
    Distribution
    20 states
  • LowFDA (Devices)·Z-1236-2017·2017-03-01

    Hidrex USA DP450 Medical Device Recalled for Documentation Requirements

    Hidrex GmbH is recalling 64 units of the Hidrex USA DP450 device because it was reclassified from Class III to Class II, triggering new documentation requirements.

    Product
    Hidrex USA DP450
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1238-2017·2017-03-01

    Hidrex Recalls Daavlin Aquex Devices Due to Documentation Requirements

    Hidrex GmbH is recalling 250 Daavlin Aquex (DAAV1000) devices nationwide because the device was reclassified from Class III to Class II, triggering new documentation requirements.

    Product
    Daavlin Aquex (DAAV1000)
    Category
    Medical Device
    Distribution
    Distributed nationwide

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