Arrow International biopsy system kits recalled for compromised anesthetic sterility
What this means
Arrow International included anesthetic medications (lidocaine and bupivacaine) and saline solution from a supplier with quality problems in its biopsy system kits. The supplier had reports of drug ineffectiveness, and compromised sterility in injectable products could cause serious injury.
- Check if you have any of the affected biopsy kit models (ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD, or ASK-09458-VU)
- Do not use kits with lot numbers listed in the FDA notice
- Contact Arrow International or your healthcare facility for instructions on returning or replacing affected kits
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-2365-2026Want us to check the next one for you?
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