Arrow International Recalls PSI and MAC 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 348,684 units of various PSI Kits, MAC Kits, and Multi-Lumen/PSI Kits distributed nationwide due to inclusion of recalled drugs with potential sterility and quality issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 3, 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 multiple PSI Kits, MAC Kits, and related central line kits after a supplier recall of Lidocaine, Bupivacaine, and 0.9% sodium chloride included in the kits. 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 348,684 units of devices including PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU4; PSI/CVC KIT: 9 FR/7 FR X 6IN (16CM)/ASK-09903-AMC1; and dozens of additional models such as ASK-09903-CMC1, ASK-09903-OSU4, ASK-11242-PHP2, ASK-21142-DMC, ASK-21142-GMC1, ASK-21242-SL1, ASK-29803-BSWH2, ASK-29903-MCY1, CDC-21142-XCN1A, and many others listed under recall number Z-2369-2026. Affected lots are identified by specific UDI-DI and batch codes. Distribution was nationwide across all 50 states, DC, and PR.
What You Should Do
Consumers and healthcare facilities should review the FDA recall notice for lot-specific information and follow any instructions provided by the recalling firm.
Why This Matters
This Class I recall involves a large volume of medical devices where compromised sterility or drug ineffectiveness poses a risk of serious or life-threatening injury.
Source
FDA recall Z-2369-2026, https://www.fda.gov
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 (1,447 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 3, 2026.
Frequently Asked Questions
Common questions about this FDA recall.