Recall Z-0166-04 ยท CAZ Anesthesia Conduction Kit
Portex Inc
Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in Dextrose and Tetracaine Catalog Number: 15545-20
| Date | Nov 27, 2003 (initiated Oct 10, 2003) |
| Status | Terminated |
| Reason | Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle. |
| Root cause | Other |
| Action | Portex notified consignees on 10/10/03 by letter issued by Federal Express. Distributors were asked to supply customer list to Portex or to notify their accounts with copy of the recall letter provided. |
| Quantity | 2600 units |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K965017 | REGIONAL ANESTHESIA TRAYS Smiths Industries Medical Systems, Inc., Mar 14, 1997 |