—#196184

Product

MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI/DI: (01)40889942604723 (case), (01)10889942604722 (kit),Lot Number 22FMF306

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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."

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution in the state of California.

Timeline

Recall initiated: 2022-09-09
Posted by FDA: 2022-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196184. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.