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Dover
Cardinal Health 200, LLC · Model 7020LL · UDI-DI 10192253068696
PPG
Prescription
0
510(k) clearances
8
Adverse events
1
Recalls
11
Facilities
Description
Urine Meter Add-A-Foley Tray, Pre-connected to 2000 mL Drainage Bag and Luer-Lock Sampling, 400 mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-15 | Stradis Healthcare | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
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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.
