Z-3181-2026Class II

Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood...

Name: Z-3181-2026 Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood...
Creator: Medical Action Industries, Inc. 306
Published: 2026-07-23
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2026-07-23 / Open, Classified

FDA source

Recall record

Recall number: Z-3181-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-23
Posted: 2026-09-16
Recalling firm: Medical Action Industries, Inc. 306
Product: Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators
Product code: OFM Phlebotomy Blood Collection Kit
Reason for recall: Blood culture convenience kits contain a component subject to a drug recall that due to an an open or incomplete seal on the packaging of the applicator may compromise the component's sterile barrier and if used may lead to localized skin or soft tissue infection.
FDA root cause: Material/Component Contamination
Action: On 7/23/2026, correction notices were emailed to customers who were asked to do the following: 1) Identify, segregate, and quarantine all impacted product. 2) Discontinue use of the BD ChloraPrep Clear - 1 mL Applicators 3) Add warning labels to affected MAI kits to ensure all users are aware of the actions to discard the impacted component prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. 4) Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 5) Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 6) Complete and return Recall Response Form via email to [email protected] Report any quality problems or adverse events associated with the products listed in this notification to [email protected].
Quantity in commerce: 6,420
Distribution: US Nationwide distribution in the states of OH, IN, NC.
Product codes and lots: 77451/20809160195069/343602(5/31/2027), 349005(10/31/2027), 374030(11/30/2027), 375434(12/31/2027), 377632(4/2/2028), 327194(8/31/2026), 375105(3/31/2028), 336074(3/21/2027); 81834B/20809160403324/326214(7/31/2027); 81834C/20809160466602/347551(8/12/2026), 372502(8/10/2026), 374615(10/21/2026), 376461(10/23/2026), 377088(11/6/2026), 373129(9/3/2026), 374033(9/3/2026)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3181-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3181-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16

Product code OFM

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)