Z-2764-2026 Class I Ongoing
FDA device recall Z-2764-2026 was initiated by Medline Industries, LP on June 8, 2026 and is designated Class I. Reason for recall: The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug i… The recall status is ongoing. Affected quantity: 52 kits.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- June 8, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 kits
Product Description
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
Reason for Recall
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
Distribution Pattern
US: Mo, CO, IL
Code Information
UDI/DI 10198459266621 (each) 40198459266622 (case), Lot Numbers: 26EDA285, 26DDA718, 26BDB740, 26ADB079, 26ADA161, 25KDB472, 25GDA213.