FDAClass IINovember 11, 2020

3/8" FloPump recall

3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only

Why was 3/8" FloPump recalled?

The firm has become aware that they have distributed product that was expired.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Lot # 042417-5045

Product
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Recalling firm
OriGen Biomedical, Inc.
Quantity
6 units
Distribution
US: TX
Recall date
November 11, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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