AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.
FDA Recall Z-1224-2017 · Posted 2017-02-17
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Recalling FirmApplied Medical Technology Inc
Recall StatusTerminated
Product CodeKNT
Date Initiated2017-01-19
Date Terminated2017-12-15
Product Quantity110
Reason for Recall
Expired expiration dates are listed on the pouches.
Firm 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.
Root Cause
Employee error
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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