FDA Recall
Terminated
Portex PEEP-KEEP Dual-Axis Swivel Adapter Catalog Number: 525351
Recall: Z-0231-05
·
Initiated September 9, 2004
Recall
- Recall Number
- Z-0231-05
- Event Number
- 29990
- Firm
- Smiths Medical ASD, Inc.
- FEI Number
- 1217052
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 9, 2004
- Posted
- November 24, 2004
- Terminated
- May 8, 2012
- Address
- 10 Bowman Dr, Keene, NH, 03431-5043
Description
Portex PEEP-KEEP Dual-Axis Swivel Adapter Catalog Number: 525351
Reason
Sterility of the device is compromised due to packaging defects
Action
Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1. On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
Distribution
Nationwide