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Terminated

Boston Scientific brand Low Profile PEG (percutaneous endoscopic gastrostomy tubes) Kit, 18/2.4, pull; Catalog number 6314.

FDA Recall Z-0962-05 · Posted 2005-07-07

Recalling FirmBoston Scientific Corp
Recall StatusTerminated
Product CodeKGC
Date Initiated2005-06-02
Date Terminated2006-12-13

Reason for Recall

Two blades may be heat staked onto the stiletto instead of the expected one blade.

Firm Action

Customers were notified by a recall letter dated 6/7/05 which instructed them to return any of the recalled products on hand.

Root Cause

Other

Distribution Pattern

Nationwide and Panama.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K910584ONE STEP BUTTON(TM)Applied Medical Technologies · 1991-05-23

Official Source

View FDA Recall →

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

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