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Dover
Cardinal Health, Inc. · Model FPP12UL · UDI-DI 10884521046702
FCN
Prescription
10
510(k) clearances
86
Adverse events (2 deaths)
3
Recalls
55
Facilities
Description
Drainage Bag with Catheter,12 Fr/Ch (4.0 mm), 5 mL Hydrogel Coated Catheter Pre-connected to 2000 mL Drainage Bag, Luer-Lock Sampling with Top Vent, Anti-Reflux Device, Drain Spout
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2011-01-11 | SteriGear, LLC | SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.