CLASS I Device recall · Reported 19 May 2021 · FDA Enforcement Report

Kit: LVAD Dres Chg recalled by Medical Action Industries

Medical Action Industries Inc. 306 is recalling Kit: LVAD Dres Chg, 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

Lot, batch or date codesKit Number: 79544B; UDI (GTIN): 20809160341855; Lot Number: 0000282089 (Expiration Date: 02/12/2022)

Quantity recalled10 cases (20 kits per case)

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-1557-2021
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: E-Mail
Reason category: Packaging Defects
Device type: Heart & Vascular 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: LVAD Dres Chg. MAI Kit Part Number: 79544B

Where it was distributed

Distributed US nationwide to OH, OR, FL and CA.

Nationwide California Florida Ohio Oregon

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: 79544B; UDI (GTIN): 20809160341855; Lot Number: 0000282089 (Expiration Date: 02/12/2022)

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 87722

Reported	Class	Recall	Company	Reason	Where
19 May 2021	CLASS I	Kit: CentralLineDresChangeClrSeq MAI Kit recalled	Medical Action Industries Inc. 306	Packaging Defects	Nationwide
19 May 2021	CLASS I	Kit: Blood Culture recalled by Medical Action Industries	Medical Action Industries Inc. 306	Packaging Defects	Nationwide
19 May 2021	CLASS I	Kit: Midline Insertion DA recalled by Medical Action Industries	Medical Action Industries Inc. 306	Packaging Defects	Nationwide
19 May 2021	CLASS I	Kit: Injection Review MAI Kit recalled by Medical Action Industries	Medical Action Industries Inc. 306	Packaging Defects	Nationwide
19 May 2021	CLASS I	Kit: Blood Culture MAI Kit recalled by Medical Action Industries	Medical Action Industries Inc. 306	Packaging Defects	Nationwide

More recalls from Medical Action Industries Inc. 306

All 24

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
12 Aug 2026Device	CLASS II	Medical Action Industries Dialysis Change Tray Clear Sequence recalled	Medical Action Industries Inc. 306	Packaging Defects	Nationwide
5 Aug 2026Device	CLASS I	Pack Angiography Ncmc 3/Cs Banner recalled by Medical Action Industries	Medical Action Industries Inc. 306	Particulate Matter	AZ, CO
13 May 2026Device	CLASS I	Medical Action Industries Inc. Pack Cath BHH recalled	Medical Action Industries Inc. 306	Other	AZ

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide