Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA
This recall has been terminated (originally issued December 24, 2003).
- Recall Initiated
- October 8, 2003
- Posted
- December 24, 2003
- Terminated
- February 9, 2004
- Recall Number
- Z-0272-04
- Quantity
- 315 units
- Firm Location
- Anasco, PR
- Official Source
- View on FDA website ↗
Reason for Recall
Lot is being recalled because some of the kits contain an incorrect guidewire.
Distribution
Distribution was to hospitals (2) in MD and DC.
Lot / Code Info
Lot no. 973H0589 Exp. date 2/2005
Root Cause
Other
Action Taken
Customers were contacted by their Edwards Sales Representatives on 10/8/03. The Sales Representatives requested that all units be returned.