FDA Device Intelligence
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Bag, Bile Collecting

FDA product code EXF · Class 2 · Gastroenterology, Urology

17
Registered devices
15
Adverse events
3
Recalls
9
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2023-11-03Remington Medical, Inc.There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
2011-01-12Remington Medical Inc.There have been complaints of the Drainage Bags leaking from the outlet and the inlet port.
2007-07-23Remington Medical Inc.Sterility, inadequate -- Pathway may not be sterile as labeled.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.