CLASS I Device recall · Reported 19 May 2021 · FDA Enforcement Report
Kit: Midline Insertion DA recalled by Medical Action Industries
Medical Action Industries, Inc. 306 is recalling Kit: Midline Insertion DA, 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-1556-2021
- 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: Midline Insertion DA. MAI Kit Part Number: 77981B
Where it was distributed
Distributed US nationwide to OH, OR, FL and CA.
Questions about this recall
Is Kit: Midline Insertion DA recalled?
Yes. Medical Action Industries, Inc. 306 recalled Kit: Midline Insertion DA on 9 Apr 2021. The recall is Class I and its status is Terminated. Recall number Z-1556-2021.
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: 77981B; UDI (GTIN): 20809160284053; Lot Number: 0000281502 (Expiration Date: 04/08/2022), 0000282039 (Expiration Date: 04/08/2022), 0000274390 (Expiration Date: 07/09/2021), and 0000279101 (Expiration Date: 11/13/2021)
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medical Action Industries, Inc. 306
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