AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
FDA Recall Z-0819-2025 · Posted 2025-01-07
Advertisement
Recalling FirmApplied Medical Technology Inc
Recall StatusCompleted
Product CodePIF
Date Initiated2024-11-26
Product Quantity100
Reason for Recall
The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.
Firm Action
An "URGENT: MEDICAL DEVICE RECALL" notification letter dated 11/26/24 was sent to customers.
ACTIONS TO BE TAKEN:
CUSTOMER OR USER:
Applied Medical Technology, Inc. requests that customers IMMEDIATELY TAKE THE FOLLOWING ACTIONS:
" Examine your inventory and isolate/quarantine pending return of the product subject to this recall.
" Do not use any device subject to this recall.
" Complete and return to Applied Medical Technology, Inc. the enclosed RECALL NOTIFICATION ACKNOWLEDGMENT via fax or send by mail.
" Please contact Applied Medical Technology, Inc. either by phone at 440-717-4000, or via email at [email protected], to make arrangements for the return of any devices related to this recall. Include the product, all of its components, and any available packaging and labeling associated with the device. An RMA number will only be issued for pouches with lot number 240424-628.
Please contact us with any questions or concerns:
Public Recall Contact: Customer Service
Address:
Applied Medical Technology, Inc.
Attn: Customer Service
8006 Katherine Blvd
Brecksville, OH 44141
USA
Telephone: 440-717-4000
Fax: 440-717-4200
Email: [email protected]
General hours of operation are 8:30am to 5:00pm. All times in Eastern Standard Time Zone.
Root Cause
Under Investigation by firm
Distribution Pattern
US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement