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Leg Bag Holder Large

FLEXICARE MEDICAL LIMITED · Model 00-0037U · UDI-DI 05055788767671

NNZ
0
510(k) clearances
4
Adverse events
1
Recalls
34
Facilities

Recalls

DateFirmReason
2015-07-10Customed, IncRecall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

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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.