ClearanceBrief
Recall Z-1223-2017 ยท KNT Tubes, Gastrointestinal (And Accessories)

Applied Medical Technology Inc

AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.

DateFeb 17, 2017 (initiated Jan 19, 2017)
StatusTerminated
ReasonExpired expiration dates are listed on the pouches.
Root causeEmployee error
ActionApplied 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
Quantity110
DistributionUS 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K030784NASOGASTRIC BRIDLE SYSTEM WITH MAGNETIC RETRIEVAL
Applied Medical Technology, Inc., Apr 1, 2004
K142971AMT Bridle - Nasal Tube Retention System
Applied Medical Technology, Inc., May 26, 2015