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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Hemovac Wound Drainage Device

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  Class 2 Device Recall Zimmer Hemovac Wound Drainage Device see related information
Date Initiated by Firm January 29, 2008
Date Posted September 19, 2008
Recall Status1 Terminated 3 on November 12, 2009
Recall Number Z-1496-2008
Recall Event ID 47233
Product Classification non-powered, portable suction appartus for a single patient - Product Code GCY
Product Zimmer Hemovac Wound Drainage Device, Infection Control Kits, Mini-Hemovac I.C. Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2557-000-10.
Code Information All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
330-365-3793
Manufacturer Reason
for Recall		 The sterility of the device may be compromised due to the possible presence of slits or pinholes in the packaging.
FDA Determined
Cause 2		 Packaging process control
Action Consignees were notified via recall letter dated 1/29/08 to locate and return the affected product. The recall action was expanded to additional products/lots via recall letter dated 3/17/08. Custom kit packers were instructed to notify their customers.
Quantity in Commerce 102,813 mini-hemovac systems
Distribution Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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