Arrow International Catheter Kits Recall
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ARROW INTERNATIONAL, LLC is recalling 126,530 units of various arterial line, vessel cath, and CVC kits distributed nationwide due to inclusion of recalled lidocaine, bupivacaine, and sodium chloride with potential sterility issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 2, 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, medical-devices.
What Happened
ARROW INTERNATIONAL, LLC initiated a voluntary recall of multiple catheter kits after a supplier recall of lidocaine, bupivacaine, and 0.9% sodium chloride included in the kits. The supplier had quality issues with limited reports of drug ineffectiveness. Compromised sterility of a water-based injectable product could lead to serious or life-threatening injuries.
Which Products Are Affected
The recall covers 126,530 units of the following products with listed REF numbers and multiple lot/batch codes: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6, RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP, ACCESS TRAY/ASK-04001-MS, RA CATH KIT: 20 GA X 8 CM/ASK-00820-UM1, VESSEL CATH KIT: 20GA X 5IN/AK-04550-S, and numerous CVC KIT models including AK-04301-SP, AK-04306-SP, AK-04800-S, AK-12402, AK-12703-CDC, AK-14402, AK-14502, AK-14553, AK-14703-SP, AK-15402, AK-15553, AK-16402, AK-16553, ASK-04301-HH2, and ASK-12703-MGH3. Distribution was nationwide across the United States 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. Recall number Z-2377-2026. Classification: Class I. Recall initiation date: 20260421.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the affected kits.
Why This Matters
This Class I recall involves a large quantity of medical devices distributed nationwide where compromised sterility could result in serious or life-threatening injuries.
Source
FDA recall Z-2377-2026. 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 (1,685 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to August 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.