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
- Company
- Applied Medical Technology Inc
- Recall Initiated
- November 10, 2020
- Terminated
- September 3, 2021
- Recall Number
- Z-0698-2021
- Firm Location
- Brecksville, OH
Reason for Recall
The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.
Distribution
US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution.
Lot / Code Info
Box Lot Number 200918-103; Pouch Lot Number 200902-075
Root Cause
Labeling Change Control
Action Taken
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.