FDA Device recall Z-1870-2016
General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit by Windstone Medical Packaging, citing 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 packagin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1870-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-21 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Windstone Medical Packaging |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | lot 56402, 57255, 60542, and 61506 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1870-2016%22
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