Windstone Medical Recalls Laparotomy Packs Due to Sterile Barrier Concerns
Windstone Medical Packaging is recalling 40 units of Laparotomy Pack Latex Free (part number 007725-7) 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 potential breach of the sterile barrier in a surgical device, which poses a risk of infection or harm to patients. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 40 units of Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. The specific component subject to recall is the Medtronic Kerlix X-Ray Detectable Laparotomy Sponges (item #4037) included in the pack.
The recall was initiated because the Medtronic Kerlix sponges were recalled due to the potential for the sterile barrier to be compromised at the packaging seal. This defect could potentially affect the sterility of the surgical instruments and sponges.
The affected units were distributed nationwide to Louisiana and Montana. The specific lot numbers involved are 55689, 55263, and 57680. Healthcare facilities and consumers who have these specific packs should stop using them and contact Windstone Medical Packaging, Inc. for further instructions or a return.
The recalled product
- Product
- Laparotomy Pack Latex Free, part number 007725-7. 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.
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 40
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 (3)
- lot 55689
- 55263
- and 57680
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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