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Coulmed

Coulmed Products Group LLC · Model A5313 · UDI-DI 10810087350496

FAQ
10
510(k) clearances
402
Adverse events
7
Recalls
121
Facilities

Description

Sterile Uro-Catcher Drain Bag; fits all hoop-style frames. Includes: Under Buttox Flaps, Mesh Filter, 6' Flexible Drain Tube with Adapter

Recalls

DateFirmReason
2023-10-19MEDLINE INDUSTRIES, LP - NorthfieldUndeclared latex
2023-10-19MEDLINE INDUSTRIES, LP - NorthfieldUndeclared latex
2023-10-19MEDLINE INDUSTRIES, LP - NorthfieldUndeclared latex
2011-06-02Teleflex MedicalSterile integrity cannot be guaranteed.
2011-06-02Teleflex MedicalSterile integrity cannot be guaranteed.
2003-04-30Medegen Medical Products, LLCFinished products were not sterilized.
2003-03-25C.R. Bard, Inc., Urological DivisionThere is a potential for package seals to be open after sterilization.

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Data 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.