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U.S. Department of Health and Human Services

Class 2 Device Recall MEDLINE

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  Class 2 Device Recall MEDLINE see related information
Date Initiated by Firm September 09, 2022
Date Posted October 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-0123-2023
Recall Event ID 90911
Product Classification General surgery tray - Product Code LRO
Product MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
Code Information UDI/DI: (01)40193489916141 (case), (01)10193489916140 (kit), Lot Number: 22FMF305
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer 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.
FDA Determined
Cause 2		 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 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."
Quantity in Commerce 760 kits
Distribution US Nationwide distribution in the state of California.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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