Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kits

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kitssee related information
Date Initiated by FirmJanuary 31, 2008
Date PostedApril 09, 2008
Recall Status1 Terminated 3 on November 12, 2009
Recall NumberZ-1452-2008
Recall Event ID 46792
Product Classification Wound Drainage Device Infection Control Kits - Product Code GCY
ProductZimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/ REF 00-2550-050-10; 400 ml Infection Control Comp. Kit, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
Code Information Lot Numbers: 60006819, 60015774, 60033386, 60045263, 60057329, 60067689, 60084095, 60094656, 60106763, 60116383, 60126841, 60145039, 60158789, 60171589, 60184524, 60200855, 60215687, 60230182, 60240753, 60262574, 60278454, 60294877, 60321541, 60333502, 60342988, 60354480, 60371375, 60385890, 60402653, 60412505, 60437090, 60471395, 60506574, 60520507, 60551036, 60570976, 60590576, 60612123 and 60626622.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
330-365-3793
Manufacturer Reason
for Recall		Leakage; The kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use.
FDA Determined
Cause 2		Process control
ActionConsignees were notified via Urgent Infection Control Recall letter dated 1/31/08 to examine their inventory and return the recalled lots. Custom kit packers were instructed in the same letter to recall these products/lots from their own customers.
Quantity in Commerce34,354 (Recalls Z-1448/1458-2008)
DistributionWorldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
Total Product Life CycleTPLC 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.
-
-