Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
Reported: May 20, 2015 Initiated: April 21, 2015 #Z-1610-2015
Product Description
Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
Reason for Recall
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.
Details
- Recalling Firm
- Zimmer Surgical Inc
- Units Affected
- 36 units
- Distribution
- Worldwide Distribution -- US, including the states of AZ, CA, ID, IL, MD, NC, RI, and SC; and, Canada.
- Location
- Dover, OH
Frequently Asked Questions
What product 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.. Recalled by Zimmer Surgical Inc. Units affected: 36 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2015. Severity: Low. Recall number: Z-1610-2015.
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