Recall Z-0819-2025 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
Applied Medical Technology Inc
AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
| Date | Jan 7, 2025 (initiated Nov 26, 2024) |
| Status | Completed |
| Reason | 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. |
| Root cause | Under Investigation by 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 |
| Quantity | 100 |
| Distribution | US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142989 | Mini ONE Enteral Extension Set Applied Medical Technology, Inc., Jan 29, 2015 |