DeviceSignal · Recall classified

Medline Industries, LP

FDA classified a device recall on 2026-08-31 · Class II · Z-3073-2026

EventRecall classified
Effective2026-08-31
ClassificationClass II

On 2026-08-31 the FDA classified a device recall from Medline Industries, LP as Class II. Product: Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD…. Recall Z-3073-2026. The firm initiated it on 2026-07-20. This reports the classification FDA published on that date.

Reported facts

Recall number
Z-3073-2026
Classification
Class II
Classified on
2026-08-31
Initiated on
2026-07-20
Firm
Medline Industries, LP
Reason
Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Product
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTURE KIT DYNDH1462B DYNDH1622C DYNDH1622D DYNDH1622F DYNDH1715B DYNDH2028 DYNDH2048 BLOOD CULTURE-NB DYNDH2089 BLOOD DRAW KIT DYLAB1081 FLOORS BLOOD DRAW KIT DYLAB1080 PEDS BLOOD CULTURE KIT DYNDH1445C PERIPHERAL BLOOD CULTURE KIT DYNDH2350 WICHITA BLOOD CULTURE COLLECT DYNDH2093

Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.

Provenance

Source
fda_device_enforcement
Source record
Z-3073-2026
Snapshot hash
2ad9ab6cbee6c5eb2f0d4298731a8c9755893d917528d78bf00a015fa69a0494
Source URL
https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
Observed
2026-09-15T12:38:10.708Z
Transform
fda_device_enforcement_to_recall v1
Event rule
fda_device_recall_classified v1
Event key
20cfb5482852e775eae58ce16bb7602bdb1b23b651c7fc760b0f73f4df957cf3
Signal type
device_recall.classified

Source terms that apply

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Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)