Arrow International PICC Access Tray recalled for compromised sterility of injectable medications
What this means
Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with known quality issues in PICC Access Tray kits. The supplier's products have reported cases of drug ineffectiveness, and compromised sterility in injectable medications can cause serious injury. About 360 kits with specific lot numbers were distributed nationwide.
- If you have a PICC Access Tray with lot numbers 33F25C0224, 33F25D0647, 33F25G0390, or 33F25J0348, do not use it.
- Contact your healthcare provider or Arrow International for instructions on safe replacement or disposal.
- Report any adverse effects or product issues 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-2395-2026Want us to check the next one for you?
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