Recall Z-0967-2024 ยท OIB Blood And Urine Collection Kit (Excludes Hiv Testing)
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
| Date | Feb 1, 2024 (initiated Dec 21, 2023) |
| Status | Open, Classified |
| Reason | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date. |
| Root cause | Error in labeling |
| Action | MEDLINE INDUSTRIES, LP issued an IMMEDIATE ACITON REQUIRED RECALL notice to its' consignees on 12/21/2023 via US mail and email. The notice explained the issue, potential risk, and requested the following actions: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit t |
| Quantity | 960 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.