Recall Z-2229-2009 ยท DQX Wire, Guide, Catheter
St. Jude Medical
St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Max. Guidewire O.D. .038", 2010-01, Manufacture, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. Used for the introduction of catheters into a vessel.
| Date | Sep 18, 2009 (initiated Aug 17, 2009) |
| Status | Terminated |
| Reason | 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 o |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 490 |
| Distribution | Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791129 | PERMANENT LEAD INTRADUCER Daig Corp., Jul 17, 1979 |