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AMT Mini Extension Set recallZ-0819-2025 · Applied Medical Technology Inc · initiated Nov 26, 2024

Completed

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Applied Medical Technology Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0819-2025
Status
Completed
Initiated by the company
Nov 26, 2024
Posted by the FDA
Jan 7, 2025
Recalling firm
Applied Medical Technology Inc
Quantity
100
Product code
PIF
FDA submissions
K142989
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 description

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

Code information (models, lots, serial numbers)

Lot Code: Model No: E6-1222 UDI-DI: (01)00842071107086(17)270401(10)240424-628 Lot number: 240424-628 Exp. Date: 2027-04-01

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

6 devices cleared under K142989 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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