St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-
FDA device recall Z-2228-2009 · posted 2009-09-18 · Terminated
Recall details
- Recalling firm
- St. Jude Medical
- Reason for recall
- St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered that the product lots could contain some items which have been mis-labeled with the incorrect French size. In one case, the pouch label does not correctly identify the content of the pouch. In another case, the carton label is incorrect. The pouch label indicated that the product was 4F catheter, but the contents of the pouch may be a 7F catheter. St. Jude Medical has not received any reports of injuries resulting from this mis-labeling.
- Action taken
- Field Representatives were sent a "St Jude Medical Urgent Product Information" letter to be hand delivered to their customers. The letter listed the products and problem and advised consignees to discontinue use of the product. A form was attached for the return of products to the firm. Contact your local St Jude Medical representative for further information.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 2,000
- Distribution
- Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium.
- Date initiated
- 2009-08-17
- Date posted
- 2009-09-18
- Date terminated
- 2011-12-17
- Location
- Minnetonka, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PERMANENT LEAD INTRADUCER (K791129) | Daig Corp. | 1979-07-17 |