Recall Z-1153-2024 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
Boston Scientific Corporation
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
| Date | Feb 16, 2024 (initiated Dec 19, 2023) |
| Status | Open, Classified |
| Reason | Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae. |
| Root cause | Under Investigation by firm |
| Action | On December 19, 2024, the firm notified affected customers via URGENT MEDICAL DEVICE PRODUCT REMOVAL letters. Customers were instructed to cease further distribution or use of any remaining affected product. Distributors should forward the notice to their customers to ensure the recall is carried out to the end-user level. Customers were instructed to discontinue use and segregate affected product. Customers will receive a Return Goods Authorization (RGA) number after completing and returning their Reply Verification Tracking Form (RVTF). Customers will receive credit for returned affected pr |
| Quantity | 0 US; 74 OUS |
| Distribution | International distribution to the country of Japan only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161003 | EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replace Boston Scientific Corporation, Jun 17, 2016 |