Recall Z-0121-2023 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
| Date | Oct 21, 2022 (initiated Sep 9, 2022) |
| Status | Open, Classified |
| Reason | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit. |
| Root cause | Process control |
| Action | Medline disseminated a recall notice titled "IMMEDIATE ACTION REQUIRED" by US mail and email on 09/16/2022and 09/23/2022. The notice requested the following: "REQUIRED ACTION: 1. Immediately check your stock for Kit Number and Kit Lot Number, listed on the destruction form, quarantine all affected product. Destroy all product belonging to the affected lot numbers listed on the destruction form. 2. Please return the completed enclosed destruction form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as i |
| Quantity | 1020 kits |
| Distribution | US Nationwide distribution in the state of California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.