Arrow International PI JACC catheter kits recalled for contaminated injectable components
What this means
Arrow International JACC catheter kits contain lidocaine, bupivacaine, and sodium chloride from a supplier with quality control problems. The injectable components may not work properly or could be sterile-compromised, risking serious infection if used.
- Check if your facility received any affected PI JACC or AGBA PI JACC kits (see lot numbers in recall notice)
- Stop using affected lots immediately and quarantine them
- Contact Arrow International or your supplier for return instructions
- Consult the full FDA recall notice for complete lot and UDI information
The agency's original wording
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-2379-2026Want us to check the next one for you?
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