Recall Z-2764-2026
- Recall number
- Z-2764-2026
- Event number
- 99297
- Firm
- Medline Industries, LP
- Firm FEI
- 1417592
- Product code
- LRO
- Status
- Open, Classified
- Initiated
- 2026-06-08
- Posted
- 2026-07-23
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K213481, K905459, K920267, K934028, K883250, K871322, K212258, K874760, K892389, K872011, K934688, K882684, K941846, K920292, K932652, K945831, K901856, K931824, K873973, K933137, K925216, K945481, K961683, K953083, K935686, K854292, K971062, K930270, K914037, K935740
Product#
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.