FDA-Device2015-05-20Class III
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
Zimmer Surgical Inc
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.
Sold states
Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.
Affected count
36 units
Manufactured in
200 W Ohio Ave, N/A, Dover, OH, United States
Products
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1610-2015Don't want to check this manually?
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