Arrow International Recalls PI JACC Kits
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Arrow International, LLC is recalling 1,516 units of various PI JACC KIT and AGBA PI JACC KIT products distributed nationwide due to inclusion of drugs from a supplier recall with potential sterility and effectiveness issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 1, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
ARROW INTERNATIONAL, LLC initiated a voluntary recall of certain PI JACC KIT products after determining that lidocaine, bupivacaine, and 0.9% sodium chloride included in the kits were subject to a supplier recall. The supplier had quality issues and limited reports of drug ineffectiveness; compromised sterility of water-based injectable products could lead to serious or life-threatening injuries.
Which Products Are Affected
The recall covers 1,516 units of the following products distributed to US Nationwide including VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR:
- 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
Specific REF, UDI-DI, and lot numbers are listed in FDA recall Z-2379-2026 (Class I).
What You Should Do
Consumers in possession of the affected kits should follow guidance associated with the supplier recall and FDA recall Z-2379-2026.
Why This Matters
This Class I recall involves products that, if sterility is compromised, could cause serious or life-threatening injuries.
Source
FDA Enforcement Report, recall number Z-2379-2026, event ID 98793.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,637 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 1, 2026.
Frequently Asked Questions
Common questions about this FDA recall.