FDAClass IIApril 6, 2022

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI recall

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Why was Gammex Non-Latex PI Green PI-KARE Skin-friendly PI recalled?

Transport company failed to stop at the border for required FDA inspection.

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?

Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604

Product
Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2
Recalling firm
Ansell Healthcare Products LLC
Quantity
74 cases
Distribution
U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None
Recall date
April 6, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls