MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756 recallZ-0124-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Sep 9, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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."
Recall details
- Recall number
- Z-0124-2023
- Status
- Open, Classified
- Initiated by the company
- Sep 9, 2022
- Posted by the FDA
- Oct 21, 2022
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 460 kits
- Product code
- LRO
- Distribution
- US Nationwide distribution in the state of California.
Product description
MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756
Code information (models, lots, serial numbers)
UDI/DI: (01)40888277983824 (case), (01)10888277983823 (kit), Lot Numbers: 22EMI516, 22DMG491
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. P164756Medline Industries, Inc. · General surgery tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90911).
- Z-0120-2023 · Open, ClassifiedMEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
- Z-0121-2023 · Open, ClassifiedMEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
- Z-0122-2023 · Open, ClassifiedMEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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