FDA Enforcement
Class III
Terminated
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: Z-0698-2021
·
Reported December 30, 2020
Enforcement
- Recall Number
- Z-0698-2021
- Event ID
- 86828
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Applied Medical Technology Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 30, 2020
- Initiation Date
- November 10, 2020
- Classification Date
- December 23, 2020
- Termination Date
- September 3, 2021
- Address
- 8006 Katherine Blvd, N/A, Brecksville, OH, 44141-4202, United States
Description
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
Reason
The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.
Code Info
Box Lot Number 200918-103; Pouch Lot Number 200902-075
Distribution
US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution.
Quantity
N/A