Portex Dual-Axis Swivel Adapter Catalog Number: 525151
FDA device recall Z-0230-05 · posted 2004-11-24 · Terminated
Recall details
- Recalling firm
- Smiths Medical ASD, Inc.
- Reason for recall
- Sterility of the device is compromised due to packaging defects
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 144,700 for all swivels
- Distribution
- Nationwide
- Date initiated
- 2004-09-09
- Date posted
- 2004-11-24
- Date terminated
- 2012-05-08
- Location
- Keene, NH
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