AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222
FDA device recall Z-0819-2025 · posted 2025-01-07 · Completed
Recall details
- Recalling firm
- Applied Medical Technology Inc
- 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.
- Action taken
- 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 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.
- Root cause
- Under Investigation by firm
- Status
- Completed
- Product code
- PIF
- Quantity affected
- 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
- Date initiated
- 2024-11-26
- Date posted
- 2025-01-07
- Location
- Brecksville, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Mini ONE Enteral Extension Set (K142989) | Applied Medical Technology, Inc. | 2015-01-29 |