Reported May 20, 2015 · Terminated
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative…
Zimmer Surgical Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Surgical Inc · 200 W Ohio Ave · Dover, OH · 44622-9642
Is this the product you have?
- Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
- Lot codes and dates
Item #00-2568-000-10Lot #62800843
- Amount recalled
- 36 units
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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