Recall Z-1268-04 ยท CAZ Anesthesia Conduction Kit
Smiths Medical ASD, Inc.
15995-20 SPINAL(SDD)25G QUINCKE W/DRUGS
| Date | Jul 30, 2004 (initiated Jul 2, 2004) |
| Status | Terminated |
| Reason | Trays contain Hospira recalled 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) Hospira, Inc. was recalling the 2ml drug vials of 5% Lidocaine Hydrochloride w/ 7.5% Dextrose lot number 09-568-DK). The drug is being recalled due to reports of particulate in the product. |
| Root cause | Other |
| Action | Smiths Medical notifed Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004. Customers and dealers are directed to fax back the attached Reply Letter |
| Quantity | 220 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.