Recall Z-0698-2021 ยท PIO Enteral Specific Transition Connectors
Applied Medical Technology Inc
AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075
| Date | Nov 10, 2020 |
| Status | Terminated |
| Reason | The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label. |
| Root cause | Labeling Change Control |
| Action | On November 10, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed that incorrect labels were used for the internal pouches of the devices subject to this recall, while the outer box has the correct label. Customers were informed that a box containing pouches with lot number 200902-075 should be returned to Applied Medical Technology, Inc. Customers were instructed to take the following immediate actions: - Do not use any device subject to this recall - Complete and return the enclosed acknowledgement form - Contact Applied Medical |
| Distribution | US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150034 | AMT Enteral Transition Adapters Applied Medical Technology, Inc., Jun 9, 2015 |