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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 Recall
Zimmer Hemovac Wound Drainage Device
see related information
Date Posted September 19, 2008
Recall Status1 Terminated on November 12, 2009
Recall Number Z-1489-2008
Recall Event ID 47233
Premarket Notification
510(K) Number
Product Classification Apparatus, Suction, Single Patient Use, Portable, Nonpowered - Product Code GCY
Product Zimmer Hemovac Wound Drainage Device, Infection Control Kits, 400ml INF. CNTRL. Kit w/ 3/32" Drain, 2,4mm, 7Fr, PVC, 107cm, small, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2550-001-10.
Code Information All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
Recalling Firm/
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
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
DESIGN: Packaging Design/Selection
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.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCY and Original Applicant = MAGNETIC RESEARCH, INC.