RecallDepth

EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.

Company
Boston Scientific Corporation One Boston
Recall Initiated
June 17, 2008
Posted
September 17, 2008
Terminated
December 10, 2008
Recall Number
Z-2236-2008
Quantity
16 Kits (total number of Kits)
Firm Location
Scientific Place Natick, MA

Reason for Recall

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

Distribution

NJ, SC, TN, VA, and WI

Lot / Code Info

Lot Number: 11712923

Root Cause

Labeling mix-ups

Action Taken

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.

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