Device recalls

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

Medical Action Industries, Inc. 306 · 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 co…

Open, ClassifiedMaterial/Component ContaminationZ-3181-2026
Open FDA's page for this record
Cfres ID
222021
Product res number
Z-3181-2026
Event date initiated
2026-07-23
Event date posted
2026-09-16
Recall status
Open, Classified
Res event number
99628
Product code
OFM
Firm FEI number
1030451
Recalling firm
Medical Action Industries, Inc. 306
Address 1
25 Heywood Rd
City
Arden
State
NC
Postal code
28704-9302
Additional info contact
Marlene Jones 470-280-4277
Root cause description
Material/Component Contamination
Product quantity
6,420
Distribution pattern
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 info

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)

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.

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 GM-OMRA_RECALLS@owens-minor.com Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.

Harmonized identifiers (openFDA)
Device name
Phlebotomy Blood Collection Kit
Medical specialty description
Cardiovascular
Regulation number
870.2750
Device class
2
Registration number
3004111573, 2321034, 9616088, 1030451, 3007329020, 1061124, 3004140833, 1825034, 1928237, 1123010, 3005012805, 1423537, 3007871198, 3035642068, 3013175547, 3013248161, 3009888344, 1643817
FEI number
3004111573, 3007329020, 1030451, 1825034, 3004140833, 1928237, 3002902735, 1000512168, 3003399884, 3005012805, 3007871198, 3035642068, 3013175547, 3013248161, 3001236905, 3009888344, 1643817, 1000123297
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.