Recall Z-0529-2024 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
PVP SOLUTION SING STRL, REF DYNDA1858
| Date | Dec 11, 2023 (initiated Nov 3, 2023) |
| Status | Open, Classified |
| Reason | The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile. |
| Root cause | Under Investigation by firm |
| Action | Medline Industries notified its consignees on 11/03/2023 via by email and US Mail (first class). The notice explained the issue and requested the destruction of any affected inventory. Distributor were directed to notify their customers. |
| Quantity | 1950 units |
| Distribution | US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.