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Recall Observatory FDA recall evidence

Device product

AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Nasointestinal (NG/NI) tubes.

Z-1224-2017

January 19, 2017

Class III

Product summary

Firm
Applied Medical Technology Inc
Event
Event 76264
Status
Terminated
Classification
Class III
Quantity
110
Official record key
device-enforcement:Z-1224-2017

Official wording

Reason: Expired expiration dates are listed on the pouches.

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Expired expiration dates are listed on the pouches.