FDA (Devices) recall action 90336
The FDA (Devices) publishes a recall like this one as 55 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 55 pages.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
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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.
McKesson is recalling Medline Centurion IV Securement Kits that were exposed to high temperatures during storage, which may have impacted product effectiveness. No illnesses have been reported.
McKesson Medical-Surgical's DisCide Ultra Surface Disinfectant Cleaner is being recalled because temperature excursions may have reduced product effectiveness. The recall affects all lots distributed nationwide between June and September 2021.
McKesson recalls hCG pregnancy test kits nationwide due to facility temperature excursions that may have compromised product effectiveness. Affected lots were received between June and September 2021.
McKesson Medical-Surgical is recalling Teleflex Arrow Central Venous Catheter Kits due to temperature excursions during storage and shipment. Exposure to higher temperatures may have reduced product effectiveness.
McKesson is recalling Wetfield Eraser Bipolar Hemostatic devices that were exposed to elevated facility temperatures from June to August 2021 prior to delivery. This exposure may have impacted the devices' effectiveness.
Beaver-Visitec medical irrigation cannulas used in LASIK eye surgery are being recalled due to storage temperature excursions. Units distributed from June through September 2021 may have reduced effectiveness.
Mckesson Medical-Surgical Inc. is recalling Fisherbrand laboratory swabs due to facility temperature excursions from June through August 2021 that may have impacted product effectiveness. All affected lots distributed between June 1 and September 30, 2021 are included.
McKesson is recalling MedSource IV Start kits due to facility temperature excursions that may have compromised product effectiveness. Affected units were received between June and September 2021.
Mckesson Medical-Surgical Inc. is recalling Excelsior Heparin Sodium prefilled syringes that may have been damaged by temperature excursions during manufacturing, potentially affecting their effectiveness. The recall covers lots received between June and September 2021.
Mckesson Medical-Surgical is recalling Centurion catheter kits that were exposed to higher temperatures during facility storage prior to delivery, which may have impacted product effectiveness. All units distributed nationwide between June 1 and September 30, 2021 are affected.
Merit Medical Systems Aspira Dressing and Drainage Kits recalled due to facility temperature excursions from June to August 2021. Exposure to higher temperatures may have reduced product effectiveness; no illnesses reported.
Mckesson is recalling a Total-Fix stool collection parasitology kit due to temperature exposure that may have reduced its effectiveness. All lots received between June 1 and September 30, 2021 are affected.
McKesson Medical-Surgical Inc. is recalling Beaver-Visitec Ultracell surgical wicks due to facility temperature excursions during storage. Temperature exposure may have impacted product effectiveness, affecting units distributed nationwide between June and September 2021.
Mckesson is recalling Ethicon SURGIFLO Hemostatic Matrix Kit due to temperature excursions during storage that may have reduced product effectiveness. Affected units were distributed nationwide between June and September 2021.
Nanosonics Sonex-HL ultrasound probe disinfectant is recalled due to temperature excursions during storage that may have affected product effectiveness.
Mckesson Medical-Surgical is recalling MetriSponge cleaning sponges due to facility temperature excursions that may have compromised product effectiveness during storage and delivery between June and August 2021.
Mckesson Medical-Surgical is recalling Dynarex cotton swabs (197 boxes) received June 1–September 30, 2021, due to temperature excursions during storage that may have reduced product effectiveness.
B. Braun EVA Gravity Mixing Container 1000 mL units may have been exposed to higher temperatures during storage prior to delivery, potentially affecting product effectiveness. Units distributed nationwide between June and September 2021 are affected.
Cadwell Disposable Ground Electrodes may have reduced effectiveness due to facility temperature excursions between June and August 2021. All units distributed nationwide received between June 1 and September 30, 2021 are affected.
Multiple Strep A diagnostic test kits are being recalled due to temperature exposure during manufacturing and storage that may have compromised test accuracy. All lots received between June 1 and September 30, 2021 are affected.
Mckesson Medical-Surgical is recalling Ultracell Eye Pledgets (Model 40825) due to temperature excursions during storage and transportation between June and August 2021 that may have compromised product effectiveness. Affected units were distributed nationwide from June through September 2021.
McKesson is recalling Alere Toxicology drug screening tablets due to temperature excursions during facility storage that may have reduced product effectiveness. Affected units were received between June and September 2021.
McKesson and Metrex Research are recalling glutaraldehyde disinfectants due to facility temperature excursions from June to August 2021 that may have reduced product effectiveness. Affected lots were distributed nationwide between June 1 and September 30, 2021.
Alere Fertility Test pregnancy test kits distributed in the US have been recalled because temperature excursions during storage may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.
Merit Medical Systems Temno soft tissue biopsy devices may have lost effectiveness due to storage temperature excursions between June and August 2021. The recall affects all lots received between June 1 and September 30, 2021.