| Class 2 Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kits | |
Date Initiated by Firm | January 31, 2008 |
Date Posted | April 09, 2008 |
Recall Status1 |
Terminated 3 on November 12, 2009 |
Recall Number | Z-1457-2008 |
Recall Event ID |
46792 |
Product Classification |
Wound Drainage Device Infection Control Kits - Product Code GCY
|
Product | Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-003-10; 400 ml evacuators and 450 ml collection bags, 3/16 in. (15 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, soft, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio |
Code Information |
Lot Numbers; 32331100, 32531400, 32944300, 33078800, 33208400, 33342100, 60006805, 60045252, 60088425, 60118920, 60174047, 60215672, 60269221, 60321524, 60385874, 60540737, 60564969, 60607918 and 60629972. |
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 |
Action | Consignees 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 Commerce | 34,354 (Recalls Z-1448/1458-2008) |
Distribution | Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore. |
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.
|
|
|
|