Device Recall AMT Bridle Nasal Tube Retaining System

Table 1: 4-4108M  Box P/N - 4-4108M  Box Lot Number - 161018-193  Box Exp. - 2019-09-01 Box UDI - (01)00842071106638(17)190901(10)161018-193  Pouch P/N - E4-4108M  Pouch Lot Number - 160930-186  Pouch Exp. - 2010-09-01  Pouch UDI - (01)00842071103934(17)100901(10)160930-186   Table 2: 4-4110  Box P/N - 4-4110  Box Lot Number - 161014-166 Box Exp. - 2019-10-01 Box UDI - (01)00842071106645(17)191001(10)161014-166  Pouch P/N - E4-4110 Pouch Lot Number - 161010-090  Pouch Exp. - 2010-10-01 Pouch UDI - (01)00842071103941(17)101001(10)161010-090   Table 3: 4-4114 Box P/N - 4-4114  Box Lot Number - 161021-139  Box Exp. - 2019-09-01 Box UDI - (01)00842071106669(17)190901(10)161021-139  Pouch P/N - E4-4114 Pouch Lot Number - 160926-242  Pouch Exp. - 2010-09-01 Pouch UDI - (01)00842071103965(17)100901(10)160926-242   Table 4: 4-4116 Box P/N - 4-4116 Box Lot Number - 161019-105  Box Exp. - 2019-09-01 Box UDI - (01)00842071106676(17)190901(10)161019-105  Pouch P/N - E4-4116  Pouch Lot Number - 161007-038  Pouch Exp. - 2010-10-01 Pouch UDI - (01)00842071103972(17)101001(10)161007-038

Gastroenterology-Urology Devices

2

No

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.

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