Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97154

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

Open FDA event record

Event summary

Timeline bucket
June 12, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
MEDLINE INDUSTRIES, LP - Northfield

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

4 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 4

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564

Z-2153-2025
Recall number
Z-2153-2025
Initiated
June 12, 2025
Classification
Class II
Status
Ongoing
Quantity
960 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open seal
Sterility assurance reason.sterility_assurance · v1.0.0
seal on its packaging. This may constitute a breach to sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.

Code information

UDI/DI 10889942754571 (EA), 40889942754572 (CASE), Lot Numbers: 24EBR566

Distribution pattern

Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.

device · product 2 of 4

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P

Z-2154-2025
Recall number
Z-2154-2025
Initiated
June 12, 2025
Classification
Class II
Status
Ongoing
Quantity
184 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open seal
Sterility assurance reason.sterility_assurance · v1.0.0
seal on its packaging. This may constitute a breach to sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.

Code information

UDI/DI 10888277797819 (EA), 40888277797810 (CASE), Lot Numbers: 24EBR549

Distribution pattern

Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.

device · product 3 of 4

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.

Z-2155-2025
Recall number
Z-2155-2025
Initiated
June 12, 2025
Classification
Class II
Status
Ongoing
Quantity
15700 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open seal
Sterility assurance reason.sterility_assurance · v1.0.0
seal on its packaging. This may constitute a breach to sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.

Code information

1) REF DYNDH1462B: UDI/DI 10195327662462 (EA), 40195327662463 (CASE), Lot Numbers: 24EBU164, 24FBD281, 24FBK195; 2) REF DYNDH1622C: UDI/DI 10195327509873 (EA), 40195327509874 (CASE), Lot Numbers: 24EBU004; 3) REF DYNDH1866: UDI/DI 10195327400958 (EA), 40195327400959 (CASE), Lot Numbers: 24EBT285.

Distribution pattern

Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.

device · product 4 of 4

Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B

Z-2156-2025
Recall number
Z-2156-2025
Initiated
June 12, 2025
Classification
Class II
Status
Ongoing
Quantity
48 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open seal
Sterility assurance reason.sterility_assurance · v1.0.0
seal on its packaging. This may constitute a breach to sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.

Code information

UDI/DI 10193489431070 (EA), 40193489431071 (CASE), Lot Numbers: 24EBR761

Distribution pattern

Distributed domestically to California, Florida, Pennsylvania, and Texas. No international distribution.