DeviceSignal · Recall classified

Medline Industries, LP

FDA classified a device recall on 2026-08-31 · Class II · Z-3070-2026

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 BLOOD…. Recall Z-3070-2026. The firm initiated it on 2026-07-20. This reports the classification FDA published on that date.

Reported facts

Recall number
Z-3070-2026
Classification
Class II
Classified on
2026-08-31
Initiated on
2026-07-20
Firm
Medline Industries, LP
Reason
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the applicator packaging. 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 BLOOD CULTURE PINK PERIPHERAL DYNDV1875 BOTTOM DRAWER ACC010972 DRAWER #4 ACC010479A DRAWER 2 ACC010690 ACC010875 DRAWER 3 SYR/DRS/MON/NG 1 OF 3 ACC011073 DRAWER 4 CIRCULATION ACC011088 DRAWER 5 - LEFT BOX ACC011067 LABOR TRIAGE KIT - LF #13232 DYKM1564 DYKM1564A LINEN UNIVERSAL PACK DYNJT10325 MAC KIT DYKS1089B NICU LINE PACK DYNJ63410 PEDIATRIC BLOOD CULTURE KIT DYNDH1363 RRMC CODE CART DRAWER 3 ACC010770 STANFORD TIME TO POSITIVITY DYNDH1591 STUDENT PRACTICE BAG W LOGO EDUC1043 EDUC1043A SUTURED SHEATH W/SCI #113198 DYKM1496 IV START KIT DYNDV2520

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-3070-2026
Snapshot hash
e8e634c086f9f5f52e82a7eef6331d8800209bbb8cbb79bd654d29f1222caae4
Source URL
https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
Observed
2026-09-23T12:43:31.676Z
Transform
fda_device_enforcement_to_recall v1
Event rule
fda_device_recall_classified v1
Event key
44cb2cdfa5e2760e99dc4f590db7fb816c0c322458ac73f6e55b3b899fe1a748
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)