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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87722

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 09, 2021
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Medical Action Industries, Inc. 306

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Kit: CentralLineDresChangeClrSeq MAI Kit Part Number: 79420

Z-1554-2021
Recall number
Z-1554-2021
Initiated
April 09, 2021
Classification
Class I
Status
Terminated
Quantity
30 cases (20 kits per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Kit Number: 79420; UDI (GTIN): 20809160247775; Lot Number: 0000276767 (Expiration Date: 01/31/2022), 0000278361 (Expiration Date: 05/31/2022), and 0000281458 (Expiration Date: 08/31/2022)

Distribution pattern

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

device · product 2 of 6

Kit: Injection REVIEW MAI Kit Part Number: 74736

Z-1555-2021
Recall number
Z-1555-2021
Initiated
April 09, 2021
Classification
Class I
Status
Terminated
Quantity
9 cases (20 kits per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Kit Number: 74736; UDI (GTIN): 20809160023720; Lot Number: 0000266521 (Expiration Date: 02/28/2022)

Distribution pattern

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

device · product 3 of 6

Kit: Midline Insertion DA. MAI Kit Part Number: 77981B

Z-1556-2021
Recall number
Z-1556-2021
Initiated
April 09, 2021
Classification
Class I
Status
Terminated
Quantity
110 cases (5 kits per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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)

Distribution pattern

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

device · product 4 of 6

Kit: LVAD Dres Chg. MAI Kit Part Number: 79544B

Z-1557-2021
Recall number
Z-1557-2021
Initiated
April 09, 2021
Classification
Class I
Status
Terminated
Quantity
10 cases (20 kits per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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

device · product 5 of 6

Kit: Blood Culture. MAI Kit Part Number: 80315D

Z-1558-2021
Recall number
Z-1558-2021
Initiated
April 09, 2021
Classification
Class I
Status
Terminated
Quantity
205 cases (20 kits per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Kit Number: 80315D; UDI (GTIN): 20809160186074; Lot Number: 0000280007 (Expiration Date: 07/31/2021), 0000280289 (Expiration Date: 06/30/2021), 0000279599 (Expiration Date: 05/31/2021), and 0000280554 (Expiration Date: 06/30/2021)

Distribution pattern

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

device · product 6 of 6

Kit: Blood Culture MAI Kit Part Number: 80076

Z-1559-2021
Recall number
Z-1559-2021
Initiated
April 09, 2021
Classification
Class I
Status
Terminated
Quantity
129 cases (20 kits per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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)

Distribution pattern

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