FDAClass IIAugust 30, 2023

Impix Manta recall

IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i)…

Why was Impix Manta 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) A20150407, GTIN 03613720236016, Lot Numbers: 18F0803, 18J0713, 18J0714, 19A0225, 19A0786, 19A0787, 19D0381, 19D0382, 19J0594, 20A0280, 20H0285, 20I0475, 20K0424, 21D0442, 21I0596, 22E0637; b) A20250407, GTIN 03613720236078, Lot Numbers: 18E0532, 18I0840, 18I0841, 18K0067, 18K0068, 18L0399, 19A0371, 19A0372, 19C0587, 19D0383, 19D0384, 19J0592, 19J0746, 19K0731, 19K0853, 20A0281, 20C0260, 20F0920, 20H0286, 20I0476, 20J0558, 20K0425, 21D0858, 21F0990, 21I0598, 22C0262, 22C0268, 22D0732, 22E0638, 22E0640, 22E0642, 22E0656, 22F0408, 22F0409; c) A20350567, GTIN 03613720236108, Lot Numbers: 18K0069, 19B0752, 19D0745, 20A0279, 20F0922, 20I0477, 21D0443, 21G0784, 22D0733, 22G0683; d) B20181743, GTIN 03613720233251, Lot Numbers: 19D0208, 19E0604, 19K0588; e) B20181753, GTIN 03613720233275, Lot Numbers: 20G0209, 20I0486, 20L0199, 21C0843; f) B20181763, GTIN 03613720233305, Lot Numbers: 18L0570, 19D0100, 19G0205, 19J0470, 20A0645; g) B20181773, GTIN 03613720233336, Lot Numbers: 19A0830, 19J0611, 19L0612, 20I0831; h) B20181943, GTIN 03613720233442, Lot Numbers: 19K0878, 20E0094, 21G0420; i) B20181953, GTIN 03613720233466, Lot Numbers: 21K0501; j) B20181963, GTIN 03613720233497, Lot Numbers: 21K0502; k) B20181973, GTIN 03613720233527, Lot Numbers: 21C0844; l) B20182253, GTIN 03613720233657, Lot Numbers: 19J0471, 19J0711, 20I0832; m) B20182263, GTIN 03613720233688, Lot Numbers: 22D0811

Product
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i)…
Recalling firm
Medicrea International
Quantity
4489 units
Distribution
US nationwide
Recall date
August 30, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls