Z-0819-2025Class II

AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222

Name: Z-0819-2025 AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Creator: Applied Medical Technology Inc
Published: 2024-11-26
License: https://open.fda.gov/license/

Applied Medical Technology Inc / initiated 2024-11-26 / Completed

FDA source

Applied Medical Technology Inc began a recall of AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222 on 2024-11-26. FDA classified it as Class II and gives the reason as "The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0819-2025
Classification: Class II
Status: Completed
Initiated: 2024-11-26
Posted: 2025-01-07
Recalling firm: Applied Medical Technology Inc
Product: AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Product code: PIF Gastrointestinal Tubes With Enteral Specific Connectors
Reason for recall: The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit connectors.
FDA root cause: Under Investigation by firm
Action: An "URGENT: MEDICAL DEVICE RECALL" notification letter dated 11/26/24 was sent to customers. ACTIONS TO BE TAKEN: CUSTOMER OR USER: Applied Medical Technology, Inc. requests that customers IMMEDIATELY TAKE THE FOLLOWING ACTIONS: " Examine your inventory and isolate/quarantine pending return of the product subject to this recall. " Do not use any device subject to this recall. " Complete and return to Applied Medical Technology, Inc. the enclosed RECALL NOTIFICATION ACKNOWLEDGMENT via fax or send by mail. " Please contact Applied Medical Technology, Inc. either by phone at 440-717-4000, or via email at [email protected], to make arrangements for the return of any devices related to this recall. Include the product, all of its components, and any available packaging and labeling associated with the device. An RMA number will only be issued for pouches with lot number 240424-628. Please contact us with any questions or concerns: Public Recall Contact: Customer Service Address: Applied Medical Technology, Inc. Attn: Customer Service 8006 Katherine Blvd Brecksville, OH 44141 USA Telephone: 440-717-4000 Fax: 440-717-4200 Email: [email protected] General hours of operation are 8:30am to 5:00pm. All times in Eastern Standard Time Zone.
Quantity in commerce: 100
Distribution: US Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA
Product codes and lots: Lot Code: Model No: E6-1222 UDI-DI: (01)00842071107086(17)270401(10)240424-628 Lot number: 240424-628 Exp. Date: 2027-04-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0819-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0819-2025	Class II	Completed	Voluntary: Firm initiated	2025-01-15	2025-01-07

Product code PIF

K142989Class IIMini ONE Enteral Extension SetApplied Medical Technology, Inc. / cleared 2015-01-29

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)