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

Medicrea International: IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C1

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: 248 units Lot/code info: a) B242C09122810, GTIN 03613720284444, Lot Numbers: 20B0926, 20B0984; b) B242C10062810, GTIN 03613720270522, Lot Numbers: 18E0499; c) B242C10122810, GTIN 03613720284451, Lot Numbers: 20B0928, 20B0985; d) B242C11062810, GTIN 03613720270539, Lot Numbers: 18D0708, 19F0261; e) B242C11122810, GTIN 03613720284468, Lot Numbers: 20B0930, 20B0986; f) B242C12062810, GTIN 03613720270546, Lot Numbers: 18D0709, 19G0038; g) B242C12122810, GTIN 03613720284475, Lot Numbers: 20B0931, 20B0987; h) B242C12123310, GTIN 03613720284543, Lot Numbers: 20C0374; i) B242C13062810, GTIN 03613720270553, Lot Numbers: 18D0710, 19F0263; j) B242C13122810, GTIN 03613720284482, Lot Numbers: 20E0343; k) B242C14122810, GTIN 03613720284499, Lot Numbers: 20B0932; l) B242C15122810, GTIN 03613720284505, Lot Numbers: 20B0933; m) B247C07062410, GTIN 03613720272762, Lot Numbers: 18D0965, 18I0576, 18L0085; n) B247C07062810, GTIN 03613720272779, Lot Numbers: 18I0577, 18L0084; o) B247C07063210, GTIN 03613720272786, Lot Numbers: 18I0492; p) B247C08062410, GTIN 03613720272533, Lot Numbers: 18D0966, 18I0579, 18L0086; q) B247C08062810, GTIN 03613720272526, Lot Numbers: 18I0554, 18I0580; r) B247C08063210, GTIN 03613720272540, Lot Numbers: 18I0493; s) B247C09062410, GTIN 03613720272557, Lot Numbers: 18D0967, 18I0582, 18L0088, 19F0264; t) B247C09062810, GTIN 03613720272564, Lot Numbers: 18H0611R, 18H0611R/1, 18I0555; u) B247C09063210, GTIN 03613720272571, Lot Numbers: 18I0494; v) B247C10062410, GTIN 03613720272588, Lot Numbers: 1

UPC codes

03613720284444, 03613720270522, 03613720284451, 03613720270539, 03613720284468, 03613720270546, 03613720284475, 03613720284543, 03613720270553, 03613720284482, 03613720284499, 03613720284505, 03613720272762, 03613720272779, 03613720272786, 03613720272533, 03613720272526, 03613720272540, 03613720272557, 03613720272564, 03613720272571, 03613720272588, 03613720272595, 03613720272601, 03613720272618, 03613720272625, 03613720272632, 03613720272649, 03613720272656, 03613720272663, 03613720272670, 03613720272687, 03613720272694, 03613720272700, 03613720272717, 03613720272724, 03613720272748, 03613720272755

Source

Official record: FDA (Device enforcement)

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

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