FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
- Recall number
- Z-0123-2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
- Status
- Open, Classified
- Initiated
- 2022-09-09
- Posted
- 2022-10-21
- Terminated
- not on file
- 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 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
- 760 kits
- Distribution
- US Nationwide distribution in the state of California.
- Lot, serial or model codes
- UDI/DI: (01)40193489916141 (case), (01)10193489916140 (kit), Lot Number: 22FMF305
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28