Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1610-2015 — Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.

U.S. FDA — Device Enforcement · United States · 2015-04-21 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1610-2015
Date of alert
2015-04-21
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Zimmer Surgical Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
62800843
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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