FDAClass IIAugust 30, 2023

Impix Tlif recall

IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i)…

Why was Impix Tlif recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) B15130607S, GTIN 03613720245681, Lot Numbers: 19B0894, 19C0092, 19G0921, 19G0922, 19L0045, 20B0320, 20B0477, 20B0478, 20B0479; b) B15130609S, GTIN 03613720245674, Lot Numbers: 18D1077, 19J0690, 20A0042, 20A0423, 20A1000, 20B0322, 20B0476, 20F0908, 20H0481, 20I0099, 20J0734; c) B15130611S, GTIN 03613720193760, Lot Numbers: 19B0895, 19D0071, 19E0170, 19I0695, 19J0324, 20A0228, 20B0731, 20B0732; d) B15130613S, GTIN 03613720193784, Lot Numbers: 18G0602, 18I0594, 19C0091, 19F0641, 19L0032, 20F0909; e) B15130615S, GTIN 03613720193807, Lot Numbers: 20I0097; f) B15900806, GTIN 03613720275572, Lot Numbers: 19A0329R; g) B15900906, GTIN 03613720275589, Lot Numbers: 19A0340R; h) B15901006, GTIN 03613720275596, Lot Numbers: 19A0339R; i) B15901106, GTIN 03613720275602, Lot Numbers: 19A0338R, 19G0337; j) B15901206, GTIN 03613720275619, Lot Numbers: 19A0337R; k) B15901306, GTIN 03613720275626, Lot Numbers: 19A0336R

Product
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i)…
Recalling firm
Medicrea International
Quantity
730 units
Distribution
US nationwide
Recall date
August 30, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls