AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
- Company
- Applied Medical Technology Inc
- Recall Initiated
- January 19, 2017
- Posted
- February 17, 2017
- Terminated
- December 15, 2017
- Recall Number
- Z-1224-2017
- Quantity
- 110
- Firm Location
- Brecksville, OH
Reason for Recall
Expired expiration dates are listed on the pouches.
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.
Lot / Code Info
Table 5: 8-1222 Box P/N - 8-1222 Box Lot Number - 161003-312 Box Exp. - 2019-09-01 Box UDI - (01)00842071108649(17)190901(10)161003-312 Pouch P/N - E8-1222 Pouch Lot Number - 160923-222 Pouch Exp. - 2016-09-01 Pouch UDI - (01)00842071107536(17)160901(10)160923-222
Root Cause
Employee error
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.