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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1223-2017 | Class III | Terminated | Voluntary: Firm initiated | ||
| Z-1224-2017 | Class III | Terminated | Voluntary: Firm initiated |
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