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Terminated

Sheath Obturator, introducer, catheter. Obturator Accessory Kit Reorder number 406405, a 6 Fr, 15 cm length Obturator supplied as a 10-pack box with 10 Individually packaged Obturators. Sterile EO. Single use. St. Jude medical, DAIG Division, Inc., Minnetonka, MN 55345-2126 USA

FDA Recall Z-0125-06 · Posted 2005-11-03

Recalling FirmSt. Jude Medical / Daig Division
Recall StatusTerminated
Product CodeDYB
Date Initiated2005-09-20
Date Terminated2006-07-22
Product Quantity2000

Reason for Recall

A lot of product contains a 6F Obturator with a hub that is incorrectly marked as 5 instead of the appropriate 6. The Obturator is correctly sized (6F) per the labeling on both the sterile bag and shelf carton.

Firm Action

A letter dated 09/20/05 was sent to all customers explaining the issue and instructed customers that a St. Jude Medical Representative will facilitate in the product removel process. Full credit will be issued.

Root Cause

Other

Distribution Pattern

CA, FL, KY, IL, MN, NY, OH, TN, VA & WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K884494DAIG OBTURATOR, CATHETER INTRODUCERDaig Corp. · 1989-02-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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