FDAClass IIJanuary 18, 2023

HCT 50ml EVA Bags recall: Sterility Concern

HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.

Why was HCT 50ml EVA Bags recalled?

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

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?

Assembly Number HCT2050, UDI-DI: M752HCT20502, Lot Number: 220130152, 221677841

Product
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Recalling firm
Stradis Healthcare
Quantity
2,779 units
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Recall date
January 18, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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