FDA Device recall Z-3068-2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
- FDA Device
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB by Medline Industries, citing 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 ap….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3068-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-20 |
| Published | 2026-09-09 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB
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.
Identifiers
| code_info | CDS983348AA UDI-DI 10195327385088 Lots 24IBK346 24JBK539; CDS983348AB UDI-DI 10198459136986 Lots 25CBF09…CDS983348AA UDI-DI 10195327385088 Lots 24IBK346 24JBK539; CDS983348AB UDI-DI 10198459136986 Lots 25CBF097 25HBB232 25HBB761 25HBH209 25HBU907 25JBQ176 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-09-30 · Medline Industries - Medline Convenience Kits: 1) MAJOR NEURO VCH, Catalog Number: DYNJ39218I
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3068-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.