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Terminated

EndoVive Safety PEG Kits 20 F Universal Product Number (UPN): MOO566460 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.

FDA Recall Z-2237-2008 · Posted 2008-09-17

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeKNT
Date Initiated2008-06-17
Date Terminated2008-12-10
Product Quantity16 Kits (total number of Kits)

Reason for Recall

Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG

Firm Action

Boston Scientific notified customers by priority Express Mail on June 17, 2008. The notification instructs accounts to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact Boston Scientific Corporation at 1-800-272-3737 for assistance.

Root Cause

Labeling mix-ups

Distribution Pattern

NJ, SC, TN, VA, and WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030855MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KITBoston Scientific Corp · 2003-04-17

Official Source

View FDA Recall →

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

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