Portex Spinal Tray with 25G Whitacre Needle. Kit contains Bupivacaine in Dextrose, Epinephrine,Lidocaine, Lidocaine in D
FDA device recall Z-0166-04 · posted 2003-11-27 · Terminated
Recall details
- Recalling firm
- Portex Inc
- Reason for recall
- Spinal trays labeled as containing a Whitacre 25g x 3.5' needle actually contain a Quincke 25g x 3.5' needle.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAZ
- Quantity affected
- 2600 units
- Date initiated
- 2003-10-10
- Date posted
- 2003-11-27
- Date terminated
- 2006-05-02
- Location
- Keene, NH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REGIONAL ANESTHESIA TRAYS (K965017) | Smiths Industries Medical Systems, Inc. | 1997-03-14 |