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FDA (Device enforcement)Recalled 2017-01-19closedclass iii

Applied Medical Technology Inc: AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.

Is my product affected?

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

  • UPC 00842071106638
  • UPC 00842071103934
  • UPC 00842071106645
  • UPC 00842071103941
  • UPC 00842071106669
  • UPC 00842071103965
  • UPC 00842071106676
  • UPC 00842071103972

Check against the official notice below — it lists the full affected range.

What happened

Applied Medical Technology Inc. is recalling 110 units of AMT Bridle nasal tube retaining systems used with nasogastric and nasointestinal tubes. The recalled products have expired expiration dates printed on the pouches. The affected products were distributed in the United States to Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Louisiana, Maine, Missouri, Minnesota, North Carolina, Ohio, Oklahoma, Oregon, Tennessee, Texas, Utah, Washington, and Wisconsin, as well as to the United Kingdom.

The recall involves four different product codes with various lot numbers. The pouches in these lots are marked with expiration dates from September 2010 to October 2010, while the boxes are marked with expiration dates in September or October 2019. The specific lot numbers and product identification codes for each affected model are detailed in the official recall record. The source does not specify what action consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Expired expiration dates are listed on the pouches.

Details from the source

Reason for recall: Expired expiration dates are listed on the pouches. 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. Quantity: 110 Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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