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FDA (Device enforcement)Recalled 2023-07-12class ii

Medicrea International: IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B1616501

Hazard

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Details from the source

Reason for recall: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. Distribution: US nationwide Quantity: 24 units Lot/code info: a) B16123509, GTIN 03613720196341, Lot Numbers: 20B0490; b) B16123511, GTIN 03613720196358, Lot Numbers: 19G0068; c) B16124009, GTIN 03613720196396, Lot Numbers: 19K0269; d) B16124013, GTIN 03613720196419, Lot Numbers: 19F0715; e) B16124509, GTIN 03613720196440, Lot Numbers: 19F0713; f) B16124511, GTIN 03613720196457, Lot Numbers: 19F0716; g) B16124513, GTIN 03613720196464, Lot Numbers: 19K0270; h) B16164009, GTIN 03613720196495, Lot Numbers: 18F1034; i) B16164013, GTIN 03613720196518, Lot Numbers: 18G0178; j) B16165009, GTIN 03613720196594, Lot Numbers: 18C0626; k) B16165013, GTIN 03613720196617, Lot Numbers: 18C0629;

UPC codes

03613720196341, 03613720196358, 03613720196396, 03613720196419, 03613720196440, 03613720196457, 03613720196464, 03613720196495, 03613720196518, 03613720196594, 03613720196617

Source

Official record: FDA (Device enforcement)

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

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