Z-0121-2023Class II

MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561

Name: Z-0121-2023 MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2022-09-09
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2022-09-09 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561 on 2022-09-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0121-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-09
Posted: 2022-10-21
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561
Product code: LRO General Surgery Tray
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1020 kits
Distribution: US Nationwide distribution in the state of California.
Product codes and lots: UDI/DI: (01)40193489402811 (case), (01)10193489402810 (kit), Lot Number 22FMF307

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0121-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0120-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-21
Z-0121-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-21
Z-0122-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-21
Z-0123-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-21
Z-0124-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-02	2022-10-21

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)