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 Medical-Surgical is recalling Cooper Surgical Milex Pessary Ring products stored at elevated temperatures from June through August 2021, which may have degraded product effectiveness.
McKesson recalls gynecological catheters that may have been exposed to temperatures higher than intended during storage, potentially affecting product effectiveness. Affected units were received between June and September 2021.
McKesson is recalling Fischer Cone Biopsy Excisor Model 900-157 units because temperature excursions during storage may have compromised product effectiveness.
3M Grounding Safety Ring pads may have been exposed to excessive temperatures during storage, potentially compromising product effectiveness. The recall affects products distributed nationwide that were received between June and September 2021.
Mckesson is recalling Morrison Medical OB Kits because facility temperature excursions may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.
McKesson recalls Coag-Sense blood coagulation test kits nationwide due to facility temperature excursions that may have affected test effectiveness.
Mckesson Medical-Surgical is recalling ABX PENTRA Creatinine reagent due to facility temperature excursions (June-August 2021) that may have impacted product effectiveness. Affected lots were received nationwide between June 1 and September 30, 2021.
Mckesson recalled 415 Perifix LOR syringes (Model 332152) distributed nationwide due to temperature excursions from June to August 2021 that may have affected product effectiveness. No illnesses have been reported.
Beckman Coulter diagnostic reagents used in blood analysis systems were recalled after exposure to temperature excursions during storage and shipment. Products received between June and September 2021 may have reduced effectiveness.
McKesson is recalling CaviCide and EnviroCide disinfectants that may have been exposed to excessive temperatures during storage from June to August 2021, potentially reducing their effectiveness.
81 kits of LeadCare II blood lead test devices were recalled because temperature exposure during storage may have impacted product effectiveness. The affected lots were received between June and September 2021.
Revital-Ox Resert hydrogen peroxide disinfectant 4-liter containers may have reduced effectiveness due to temperature exposure during storage. McKesson is recalling affected lots distributed June-September 2021.
McKesson is recalling Medefil Normal Saline IV Flush Syringes (Models MIS-1130 and 191-MIS-1130) due to facility temperature excursions between June and August 2021. Products received through September 30, 2021 may have impaired effectiveness from temperature exposure prior to delivery.
ABX Pentra Etching CP solution is recalled due to temperature excursions from June-August 2021 that may have affected product effectiveness. Affected lots were distributed June 1 - September 30, 2021.
The GETINGE OCEAN Chest Drain System Atrium 2100 mL is being recalled due to facility temperature excursions from June-August 2021 that may have impacted product effectiveness. Affected units were distributed nationwide between June 1 and September 30, 2021.
McKesson Medical-Surgical is recalling multiple brands of drugs of abuse test kits because temperature excursions prior to delivery may have reduced product effectiveness.
McKesson Medical-Surgical is recalling MMS - IMMUNOSTICS INC colorectal cancer screening test kits due to facility temperature excursions that may have reduced product effectiveness. The recall affects lots distributed between June and September 2021.
B. Braun Medical Inc. is recalling Anesthesia Support Trays distributed between June and September 2021 due to temperature excursions during storage that may have affected product effectiveness.
Mckesson Medical-Surgical is recalling Medline catheter plugs (Model DYND12200) due to temperature excursions that may have impacted effectiveness. All lots received between June 1 and September 30, 2021 are affected.
Mckesson Medical-Surgical is recalling Fisher Scientific Sure-Vue RPR Dispensing Pipettes due to temperature excursions during storage from June to August 2021. Exposure to higher temperatures may have impacted product effectiveness.
Mckesson Medical-Surgical is recalling Fisher Scientific Aseptic Control Lubricating Jelly due to temperature excursions from June–August 2021 that may have reduced product effectiveness.
BD Vacutainer blood collection tubes are recalled due to potential temperature damage during storage from June to August 2021. Affected tubes received between June 1 and September 30, 2021 may have reduced effectiveness.
Mckesson is recalling Dynarex DynaLube lubricating jelly due to facility temperature excursions from June-August 2021 that may have degraded product effectiveness. Recall affects 17.5 boxes distributed nationwide between June-September 2021.
McKesson Medical-Surgical is recalling multiple medical devices that experienced temperature excursions during storage and transport. Exposure to higher temperatures from June through August 2021 may have reduced product effectiveness.
Mckesson Medical-Surgical initiated a voluntary nationwide recall of Fisherbrand SWAB TRANS STUARTS swabs. The specific reason for the recall is not documented in the FDA notice.