Recall Z-2395-2026
- Recall number
- Z-2395-2026
- Event number
- 98793
- Firm
- ARROW INTERNATIONAL, LLC
- Firm FEI
- 3013162291
- Product code
- LJT
- Status
- Open, Classified
- Initiated
- 2026-04-21
- Posted
- 2026-06-13
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K003006, K982507, K863305, K924250, K952548, K961652, K932095, K010189, K131694, K022110, K870886, K141146, K122767, K150733, K102385, K853981, K872898, K921201, K032044, K082126, K896093, K931748, K875213, K934167, K942024, K153359, K841679, K905843, K870519, K863296
Product#
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
Reason for Recall#
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.