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.
Reported: June 8, 2016 Initiated: March 21, 2016 #Z-1870-2016
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Windstone Medical Packaging, Inc.
- Units Affected
- 170 units
- Distribution
- Nationwide distribution to Louisiana and Montana.
- Location
- Billings, MT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Windstone Medical Packaging, Inc.. Units affected: 170 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 8, 2016. Severity: Moderate. Recall number: Z-1870-2016.
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