FDA Recall
Terminated
Bard Orbiter PV Steerable Catheter Item #: 320100 (Marketed in Europe Only)
Recall: Z-0603-03
·
Initiated January 8, 2003
Recall
- Recall Number
- Z-0603-03
- Event Number
- 25401
- Firm
- C. R.Bard, Inc./Electrophysiology Division
- FEI Number
- 1000120754
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- January 8, 2003
- Posted
- February 28, 2003
- Terminated
- May 3, 2012
- Address
- 129 Concord Road, Billerica, MA, 01821
Description
Bard Orbiter PV Steerable Catheter Item #: 320100 (Marketed in Europe Only)
Reason
Sterile barrier maybe perforated compromising sterility of the device
Action
Bard Electrophysiology notified direct accounts by letter on 1.08.03 via Fed''X. Accounts are requested to return product.
Distribution
Nationwide
Quantity
12 units