St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-01, Manufacturer, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. Used for the introduction of catheters into a vessel.
FDA Recall Z-2228-2009 · Posted 2009-09-18
Advertisement
Recalling FirmSt. Jude Medical
Recall StatusTerminated
Product CodeDQX
Date Initiated2009-08-17
Date Terminated2011-12-17
Product Quantity2,000
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement