Recall Z-0698-2021— Applied Medical Technology Inc
Class III · Terminated
Class III FDA medical device recall by Applied Medical Technology Inc, initiated 2020-11-10, terminated 2021-09-03. It names one FDA 510(k) clearance: K150034. Product: 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..
- Recalling firm
- Applied Medical Technology Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2020-11-10
- Terminated
- 2021-09-03
- Firm location
- Brecksville, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.