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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.

Recommended Action

Per FDA guidance

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 Technology, Inc. to make arrangements for the return of any devices related to the recall. - Continue to inspect and prepare any devices prior to use according to its standard operating procedures and good medical practices.