Laparotomy Pack recall: Sterility Concern
Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in…
Why was Laparotomy Pack 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: 55950, 56349, 57461, 58034, 58492, 70671, 70930, 71324, 71726, 71892, 72656, 73071, 74331, 75004, and 75545.
- Product
- Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in…
- Recalling firm
- Windstone Medical Packaging, Inc.
- Quantity
- 386 units
- Distribution
- Nationwide distribution to Louisiana and Montana.
- Recall date
- June 8, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)