CLASS I Device recall · Reported 19 May 2021 · FDA Enforcement Report
Kit: Blood Culture MAI Kit recalled by Medical Action Industries
Medical Action Industries Inc. 306 is recalling Kit: Blood Culture MAI Kit, distributed nationwide in the US. The recall was initiated on 9 Apr 2021 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1559-2021
- FDA event ID
- 87722
- Recalling firm
- Medical Action Industries Inc. 306, Arden, NC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Apr 2021
- FDA classified
- 12 May 2021
- Reported
- 19 May 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 9 Apr 2021 | Recall initiated by company | |
| 12 May 2021 | Classified by FDA | +33 days |
| 19 May 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Kit: Blood Culture MAI Kit Part Number: 80076
Where it was distributed
Distributed US nationwide to OH, OR, FL and CA.
Questions about this recall
Why was it recalled?
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
Which lots are affected?
Kit Number: 80076; UDI (GTIN): 20809160021269; Lot Number: 0000280292 (Expiration Date: 07/31/2021), 0000280766 (Expiration Date: 07/31/2021), 0000281206 (Expiration Date: 07/31/2021), 0000279153 (Expiration Date: 05/31/2021), and 0000280969 (Expiration Date: 06/30/2021)
Where was it sold?
Distributed US nationwide to OH, OR, FL and CA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 87722This product is part of a recall event; the main page for the event is Kit: LVAD Dres Chg recalled by Medical Action Industries.
More recalls from Medical Action Industries Inc. 306
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Medical Action Industries Dialysis Change Tray Clear Sequence recalled | Medical Action Industries Inc. 306 | Packaging Defects | Nationwide |
| Device | CLASS I | Pack Angiography Ncmc 3/Cs Banner recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Particulate Matter | AZ, CO |
| Device | CLASS I | Medical Action Industries Inc. Pack Cath BHH recalled | Medical Action Industries Inc. 306 | Other | AZ |
Other Other Medical Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |