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FDAApril 21, 2015device

Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Devices were placed in a shipper carton without the appropriate number of the Instructions for Use (IFU). Packaging specifications require that each sales unit is accompanied by an IFU. Only one IFU was present in the shipper carton, instead of one IFU per each of the two sales units.

What to do

FDA enforcement status: Terminated

Brands named

zimmer surgicalzimmer

UPCs

00256800010

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage. — Recall Details · AllClear