Z-0698-2021Class III

AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI...

Name: Z-0698-2021 AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI...
Creator: Applied Medical Technology Inc
Published: 2020-11-10
License: https://open.fda.gov/license/

Applied Medical Technology Inc / initiated 2020-11-10 / Terminated / root cause: labeling and UDI

FDA source

Applied Medical Technology Inc began a recall of 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... on 2020-11-10. FDA classified it as Class III and gives the reason as "The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0698-2021
Classification: Class III
Status: Terminated
Initiated: 2020-11-10
Posted: 2020-12-23
Terminated: 2021-09-03
Recalling firm: Applied Medical Technology Inc
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
Product code: PIO Enteral Specific Transition Connectors
Reason for recall: The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.
Root cause tag: labeling and UDI
FDA 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 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.
Distribution: US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution.
Product codes and lots: Box Lot Number 200918-103; Pouch Lot Number 200902-075

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0698-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0698-2021	Class III	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-23

Product code PIO

K150034Class IIAMT Enteral Transition AdaptersApplied Medical Technology, Inc. / cleared 2015-06-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)