| Class 3 Device Recall AMT Feeding Set | |
Date Initiated by Firm | January 19, 2017 |
Date Posted | February 17, 2017 |
Recall Status1 |
Terminated 3 on December 15, 2017 |
Recall Number | Z-1224-2017 |
Recall Event ID |
76264 |
510(K)Number | K030784 K142971 |
Product Classification |
Tubes, gastrointestinal (and accessories) - Product Code KNT
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Product | AMT 12 inch Right Angle Feeding Set with Y-Port
Used with Nasogastric/Nasointestinal (NG/NI) tubes. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Applied Medical Technology Inc 8000 Katherine Blvd Brecksville OH 44141-4202
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For Additional Information Contact | Customer Service 440-717-4000 |
Manufacturer Reason for Recall | Expired expiration dates are listed on the pouches. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KNT
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