Windstone Medical Packaging Recalls Laparotomy Packs Due to Sterile Barrier Concerns
Windstone Medical Packaging is recalling specific Laparotomy Packs because the included Medtronic Kerlix sponges may have compromised sterile barriers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential sterile barrier compromise, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 386 units of Laparotomy Packs, part numbers 006268-8 and 007725-8. These are custom convenience surgical instrument disposable kits. The specific component subject to recall within these packs is the Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" W/L.
The recall was initiated because the included Kerlix X-ray Detectable Laparotomy Sponges were recalled by Medtronic due to the potential for the sterile barrier to be compromised at the packaging seal. This defect could affect the sterility of the surgical instruments.
The affected products were distributed nationwide to Louisiana and Montana. The lots involved are 55950, 56349, 57461, 58034, 58492, 70671, 70930, 71324, 71726, 71892, 72656, 73071, 74331, 75004, and 75545. Healthcare facilities and consumers should stop using these packs and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x…
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- Affected units
- 386
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lot: 55950
- 56349
- 57461
- 58034
- 58492
- 70671
- 70930
- 71324
- 71726
- 71892
- 72656
- 73071
- 74331
- 75004
- and 75545.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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