FDAClass IIJune 8, 2016

Laparotomy Pack Latex Free recall: Sterility Concern

Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. There are multiple component in…

Why was Laparotomy Pack Latex Free recalled?

These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.

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 55689, 55263, and 57680

Product
Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. There are multiple component in…
Recalling firm
Windstone Medical Packaging, Inc.
Quantity
40 units
Distribution
Nationwide distribution to Louisiana and Montana.
Recall date
June 8, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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