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U.S. Department of Health and Human Services

Class 2 Device Recall Applied Medical Technology, Inc.

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 Class 2 Device Recall Applied Medical Technology, Inc.see related information
Date Initiated by FirmNovember 26, 2024
Date PostedJanuary 07, 2025
Recall Status1 Completed
Recall NumberZ-0819-2025
Recall Event ID 95881
510(K)NumberK142989 
Product Classification Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
ProductAMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
Code Information Lot Code: Model No: E6-1222 UDI-DI: (01)00842071107086(17)270401(10)240424-628 Lot number: 240424-628 Exp. Date: 2027-04-01
FEI Number 1526012
Recalling Firm/
Manufacturer		 Applied Medical Technology Inc
8006 Katherine Blvd
Brecksville OH 44141-4202
For Additional Information ContactDan Filler
440-7174000
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionAn "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 cs@appliedmedical.net, 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: cs@appliedmedical.net General hours of operation are 8:30am to 5:00pm. All times in Eastern Standard Time Zone.
Quantity in Commerce100
DistributionUS Distribution to states of: CA, CT, FL, GA, IL, MA, MD, MO, NC, NJ, NY, OH, OK, PA, SC, TX, VA, WA
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database510(K)s with Product Code = PIF
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