FDAClass IIAugust 25, 2021

WOLF-PAK Self Safe Safety IV Catheter: a) recall: Sterility Concern

WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

Why was WOLF-PAK Self Safe Safety IV Catheter: a) recalled?

Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

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) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084

Product
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Recalling firm
Delta Med SpA
Quantity
40,000 units
Distribution
US Nationwide distribution in the states of FL and MN.
Recall date
August 25, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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