Recall Z-1868-2016 ยท LRS I.V. Start Kit
Windstone Medical Packaging, Inc.
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 32" W/L.
| Date | Mar 21, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Packaging |
| Action | Aligned Medical Solutions (AMS) sent the Urgent Medical Device Recall letter, dated March 21, 2016, and the Recall Reply Form to their consignees via email. AMS informed consignees that their AMS packs (surgical kits) contained Kerlix X-Ray Detectable Laparotomy Sponge which was recalled by Medtronic. Consignees were advised to follow the over-labeling instructions and dispose the Kerlix X-Ray Detectable Laparotomy Sponge at the time the surgical kit is opened for use. Consigneeswere instructed to follow the "Instruction for placing Recall Notice Label to Packs" and label any kits remain |
| Quantity | 386 units |
| Distribution | Nationwide distribution to Louisiana and Montana. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.