Windstone Medical Recalls General Surgery Packs with Medtronic Sponges
Windstone Medical Packaging is recalling General Surgery Packs containing Medtronic Kerlix sponges due to potential sterile barrier compromise at the packaging seal.
What this means for you
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 sterile barrier compromise in a medical device, which poses a risk of infection or harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling General Surgery Packs, part number 006880-3. These are custom convenience surgical instrument disposable kits. The specific component subject to this recall is the Medtronic Kerlix X-Ray Detectable Laparotomy Sponges (item #4037) included in the packs.
The recall is being conducted 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 affect the sterility of the surgical instruments.
A total of 170 units were distributed nationwide to Louisiana and Montana. The affected lots are 56402, 57255, 60542, and 61506. Healthcare facilities and consumers should stop using these packs and contact Windstone Medical Packaging for further instructions.
The recalled product
- Product
- General Surgery Pack, part number 006880-3. 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
- 170
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 (4)
- lot 56402
- 57255
- 60542
- and 61506
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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