Arrow International drainage and thoracentesis kits recalled for potentially non-sterile anesthetic injectables
Arrow International medical kits recalled for compromised anesthetic sterility
Arrow International included anesthetic medications (lidocaine and bupivacaine) and saline solution from a supplier with quality issues in multiple drainage, thoracentesis, and pneumothorax kits. If these injectable products lost sterility during manufacturing or storage, they could cause serious infection or treatment failure.
- Check if your facility has any of the affected kit models: AK-01600, AK-01601, ASK-01601-MM, AK-01000-T, AK-01000, ASK-01000-CHP, ASK-01000-NW, ASK-01000-UPMS, AK-01500, ASK-01500, or ASK-01500-JCM
- Do not use the recalled kits; contact Arrow International or your supplier for replacement or credit
- Review lot numbers (beginning 33F or 33R) on packaging to confirm if your stock is affected
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2382-2026More ARROW INTERNATIONAL, LLC recalls
- FDA-Device2026-06-24Arrow International epidural catheter kits recalled for potentially compromised anesthetic sterility
- FDA-Device2026-06-24Arrow International hemodialysis and AHDC kits recalled for contaminated injectable anesthetics and saline
- FDA-Device2026-06-24Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JACC KIT: 1-L 4.5 FR X 20 CM/CDC-42041-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 20 CM/CDC-42052-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 20 CM/CDC-42063-JX1A
- FDA-Device2026-06-24Arrow International central venous catheter kits recalled for compromised sterility and drug ineffectiveness
- FDA-Device2026-06-24Arrow International paracentesis kit recalled for contaminated anesthetic drugs
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