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Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451 recallZ-3181-2026 · Medical Action Industries, Inc. 306 · initiated Jul 23, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Medical Action Industries, Inc. 306 or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

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 category: Material/Component Contamination

What the company is doing

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].

Recall details

Recall number
Z-3181-2026
Status
Open, Classified
Initiated by the company
Jul 23, 2026
Posted by the FDA
Sep 16, 2026
Recalling firm
Medical Action Industries, Inc. 306
Quantity
6,420
Product code
OFM
Distribution
US Nationwide distribution in the states of OH, IN, NC.

Product description

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

Code information (models, lots, serial numbers)

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)

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page