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Recall Observatory FDA recall evidence

Device product

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

Z-1610-2015

April 21, 2015

Class III

Product summary

Firm
Zimmer Surgical Inc
Event
Event 71057
Status
Terminated
Classification
Class III
Quantity
36 units
Official record key
device-enforcement:Z-1610-2015

Official wording

Reason: 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.

Code information: Item #00-2568-000-10; Lot #62800843

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.