Recall Z-2396-2026
- Recall number
- Z-2396-2026
- Event number
- 98793
- Firm
- ARROW INTERNATIONAL, LLC
- Firm FEI
- 3013162291
- Product code
- FMF
- Status
- Open, Classified
- Initiated
- 2026-04-21
- Posted
- 2026-06-13
- Root cause
- Nonconforming Material/Component
- 510(k) numbers
- K781978, K864407, K123766, K171805, K223453, K024052, K193273, K761158, K231877, K172670, K002569, K840083, K072345, K231792, K923321, K924072, K883033, K861686, K901203, K882536, K103736, K211211, K162081, K253769, K992404, K062260, K822159, K994230, K843414, K930321
Product#
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711
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.