MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
- Recall Initiated
- September 9, 2022
- Posted
- October 21, 2022
- Recall Number
- Z-0121-2023
- Quantity
- 1020 kits
- Firm Location
- Northfield, IL
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of California.
Lot / Code Info
UDI/DI: (01)40193489402811 (case), (01)10193489402810 (kit), Lot Number 22FMF307
Root Cause
Process control
Action Taken
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 indicated on the destruction form. When we receive your completed destruction form your account will be issued a credit, if applicable. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. If you have any questions, please contact 866-359-1704."