CLASS III Device recall · Reported 1 Mar 2017 · FDA Enforcement Report
AMT Bridle - Nasal Tube Retaining System Used recalled
Applied Medical Technology is recalling AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI), distributed in 20 states. The recall was initiated on 19 Jan 2017 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1223-2017
- FDA event ID
- 76264
- Recalling firm
- Applied Medical Technology, Brecksville, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Jan 2017
- FDA classified
- 17 Feb 2017
- Reported
- 1 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Jan 2017 | Recall initiated by company | |
| 17 Feb 2017 | Classified by FDA | +29 days |
| 1 Mar 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Expired expiration dates are listed on the pouches.
Product as listed by the FDA
AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes.
Where it was distributed
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.
ArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIdahoLouisianaMaineMinnesotaMissouriNorth CarolinaOhioOklahomaOregonTennesseeTexasUtahWashingtonWisconsin
Questions about this recall
Why was it recalled?
Expired expiration dates are listed on the pouches.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 76264This product is part of a recall event; the main page for the event is AMT Right Angle Feeding Set with Y-Port Used recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | AMT Right Angle Feeding Set with Y-Port Used recalled | Applied Medical Technology | Other | 20 states |
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