Arrow International hemodialysis kits recalled for contaminated anesthetic and saline solutions
What this means
Arrow International hemodialysis kits contain lidocaine, bupivacaine, and saline solution from a supplier with quality control problems. The contaminated materials may not work as intended, and compromised sterility in injectable products could cause serious harm to patients.
- If you use these hemodialysis kits, contact your healthcare provider or hospital immediately with your kit model number and lot number.
- Do not use affected kits. Check the lot numbers listed in the recall notice against your current inventory.
- Report any adverse effects or product concerns to the FDA MedWatch program.
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-2373-2026Want us to check the next one for you?
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