Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1224-2017Class III

AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes

Applied Medical Technology Inc / initiated 2017-01-19 / Terminated / root cause: manufacturing process

Applied Medical Technology Inc began a recall of AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes on . FDA classified it as Class III and gives the reason as "Expired expiration dates are listed on the pouches". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1224-2017
Classification
Class III
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Applied Medical Technology Inc
Product
AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall
Expired expiration dates are listed on the pouches.
Root cause tag
manufacturing process
FDA root cause
Employee error
Action
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.
Quantity in commerce
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.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1224-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1223-2017Class IIITerminatedVoluntary: Firm initiated
Z-1224-2017Class IIITerminatedVoluntary: Firm initiated