Z-2455-2026 Class I Ongoing
FDA device recall Z-2455-2026 was initiated by Medline Industries, LP on May 6, 2026 and is designated Class I. Reason for recall: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality… The recall status is ongoing. Affected quantity: 503 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- May 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 503 units
Product Description
Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEART A OVERHEAD, Model Number: DYNJ910066; 3) OPEN HEART, Model Number: DYNJ9855016V; 4) OPEN HEART, Model Number: DYNJ9855016X
Reason for Recall
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality issues identified during a recent FDA inspection of the supplier.
Distribution Pattern
US Nationwide.
Code Information
1) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25BDA811; 2) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDB415; 3) ACC010890, UDI-DI: 10198459139833(each), 40198459139834(case), Lot Number: 25DDC095; 4) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25ADB324; 5) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25FDB473; 6) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 25GDA336; 7) DYNJ910066, UDI-DI: 10195327565596(each), 40195327565597(case), Lot Number: 24FDB427; 8) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25ABH622; 9) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBA788; 10) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25CBF665; 11) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25DBR616; 12) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25FBA415; 13) DYNJ9855016V, UDI-DI: 10198459019951(each), 40198459019952(case), Lot Number: 25HBT666; 14) DYNJ9855016X, UDI-DI: 10198459571374(each), 40198459571375(case), Lot Number: 25KBO109