AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
FDA device recall Z-1224-2017 · posted 2017-02-17 · Terminated
Recall details
- Recalling firm
- Applied Medical Technology Inc
- Reason for recall
- Expired expiration dates are listed on the pouches.
- Action taken
- Applied Medical Technology Inc. sent an Urgent Medical Device Recall letter dated January 19, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTIONS TO BE TAKEN BY THE CUSTOMER OR USER: Applied Medical Technology requests that customers IMMEDIATELY TAKE THE ACTION and return all devices in inventory subject to this recall. Do not use any device subject to this recall. Complete and return to Applied Medical Technology the enclosed RECALL NOTIFICATION. For further questions please call (440) 717- 4000.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 110
- Distribution
- US Distribution to the states of : AZ, CA, CO, CT, FL, GA, ID, LA, ME, MO, MN, NC, OH, OK, OR, TN, TX, UT, WA, and WI., and to the United Kingdom.
- Date initiated
- 2017-01-19
- Date posted
- 2017-02-17
- Date terminated
- 2017-12-15
- Location
- Brecksville, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AMT Bridle - Nasal Tube Retention System (K142971) | Applied Medical Technology, Inc. | 2015-05-26 |
| NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL (K030784) | Applied Medical Technology, Inc. | 2004-04-01 |