Recall Z-1610-2015— Zimmer Surgical Inc
Class III · Terminated
Class III FDA medical device recall by Zimmer Surgical Inc, initiated 2015-04-21, terminated 2015-11-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.. 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..
- Recalling firm
- Zimmer Surgical Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-04-21
- Terminated
- 2015-11-06
- Firm location
- Dover, OH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.