Recall Z-1550-2022 ยท OXQ Dressing Change Tray
Trinity Sterile, Inc.
Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
| Date | Jun 29, 2022 |
| Status | Terminated |
| Reason | Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy |
| Root cause | Labeling design |
| Action | Trinity Medical issued Urgent Medical Device Correction Letter dated June 30, 2022 via email as a follow-up to the call on 6/29/22. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory for the affected products and lot numbers identified on the attached spreadsheet. If you have affected stock in inventory, immediately discontinue use and quarantine the products. If you have transferred any of the affected kits to a third party, please communicate this information to them. 2. Notify Trinity. Please complete the enclosed Customer Response Form as soon as pos |
| Quantity | 2,512 cases (75,360 eaches ) |
| Distribution | US Nationwide distribution in the states of FL, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.