Z-2236-2008

EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition...

Name: Z-2236-2008 EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition...
Creator: Boston Scientific Corporation
Published: 2008-06-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2008-06-17 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition directly into the stomach of adult and pediatric... on 2008-06-17. The reason FDA records is "Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2236-2008
Status: Terminated
Initiated: 2008-06-17
Posted: 2008-09-17
Terminated: 2008-12-10
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 16 Kits (total number of Kits)
Distribution: NJ, SC, TN, VA, and WI
Product codes and lots: Lot Number: 11712923

Product code KNT

K030855Class IIModification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety KitBoston Scientific Corp / cleared 2003-04-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)