Zimmer Surgical Inc recalls Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative…

Recall date

April 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1610-2015

FDA classification

Class III

Brand / firm

Zimmer Surgical Inc

Sold / distributed

Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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