Arrow International Recalls Arterial Line Kits and RA Cath 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 785,999 units of various arterial catheterization and RA cath kits nationwide due to inclusion of lidocaine, bupivacaine, and 0.9% sodium chloride from a supplier with 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 arterial line kits and RA cath kits after discovering that lidocaine, bupivacaine, and 0.9% sodium chloride subject to a supplier recall were included in the kits. The supplier had quality issues with limited reports of drug ineffectiveness. If sterility of a water-based injectable product is compromised, this could lead to serious or life-threatening injuries.
Which Products Are Affected
The recall covers 785,999 units of the following products distributed 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, and PR:
- RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1
- RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S1A
- ARTERIAL LINE KIT/AK-04510-S
- ARTERIAL CATH KIT: 18 GA X 6IN (16 CM)/ASK-04018-HUMC
- ARTERIAL LINE KIT: 18 GA X 6 IN (16 CM)/ASK-04018-OH1
- And numerous additional RA CATH KIT, ARTERIAL LINE KIT, ARTERIAL CATH KIT, CVC KIT, and ARTERIAL ACCESS TRAY models with REF numbers including ASK-04020-BID, ASK-04020-MAR, ASK-04020-PM4, ASK-04120-HF3, ASK-04120-UR, ASK-04125-MGH, ASK-04500-HFH4, ASK-04510-BID2, ASK-04510-EHP1, ASK-04510-FEM1, ASK-04510-HFH, ASK-04510-HFH4, ASK-04510-SE, ASK-04510-TGH2, NA-04550-1A, NA-04550-X1A, AK-04018, AK-04020, AK-04020-C, AK-04120, AK-04122, AK-04220, and many more (full list available in FDA recall Z-2368-2026).
What You Should Do
Consumers should stop using the affected products and contact Arrow International, LLC for return or refund instructions.
Why This Matters
This Class I recall involves nearly 786,000 devices distributed across the United States, where compromised sterility in included injectable drugs could result in serious or life-threatening injuries.
Source
FDA recall number Z-2368-2026, initiated April 21, 2026.
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 (1,957 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.