Arrow International PI Midline midline catheter kits recalled for potential sterility compromise
What this means
Arrow International included anesthetic and saline solutions from a supplier with documented quality issues in PI Midline midline catheter kits. The supplier's products showed signs of ineffectiveness and potential sterility problems, which could compromise the safety of these injectable medical devices.
- Check your facility or clinic for PI Midline kits with lot number 33F24L0236 and UDI-DI 10801902193275
- Do not use affected kits; contact Arrow International or the FDA for return instructions
- Review patient records if kits were used and consult your healthcare provider or facility infection control
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-2387-2026Want us to check the next one for you?
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