ARROW INTERNATIONAL, LLC — Class I: Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X
Arrow International, LLC has initiated a Class I recall of various Pressure Injectable (PI) JACC kits due to quality issues with supplier-provided Lidocaine, Bupivacaine, and 0.9% sodium chloride. These water-based injectable components were reported to have potential sterility compromises and limited instances of drug ineffectiveness.
This recall affects healthcare facilities and practitioners using specific Arrow International PI JACC and AGBA PI JACC kits, as well as Quality and Supply Chain departments managing convenience kit components.
A Class I designation indicates that the FDA considers the defect to have a reasonable probability of causing serious adverse health consequences or death, specifically regarding compromised sterility in injectable products. This case highlights the significant regulatory risk inherent in convenience kit manufacturing, where the primary manufacturer remains responsible for the quality of third-party drug components included in the final device configuration.
Regulatory and Quality teams should immediately verify if affected kit lot numbers are in inventory or clinical use. Firms utilizing third-party drug components in convenience kits should review supplier audit histories and sterility assurance documentation to mitigate similar subcontracted risks.
Class I. Reason: 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.. Product: Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JACC KIT: 1-L 4.5 FR X 20 CM/CDC-42041-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 20 CM/CDC-42052-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 20 CM/CDC-42063-JX1A. Firm: ARROW INTERNATIONAL, LLC (Morrisville NC United States). Status: Ongoing.
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