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Terminated

Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set; REF/catalog no. 27-135. Universal Product Number (UPN) M001271350.

FDA Recall Z-0081-2007 · Posted 2006-10-28

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeFFA
Date Initiated2006-09-21
Date Terminated2007-05-03
Product Quantity80

Reason for Recall

Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.

Firm Action

Consignees were notified by letter dated 9/21/06 to discontinue use of recalled product, and to segregate the recalled product, and to follow instructions for responding to the firm and returning the product.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K944290CATHETERS, BILIARY CATHETERS, UROLOGICALBoston Scientific Corp · 1994-12-08

Official Source

View FDA Recall →

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

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