Arrow International Hemodialysis Kit Recall
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ARROW INTERNATIONAL, LLC is recalling 1,945 hemodialysis kits distributed nationwide because they contain drugs subject to a supplier recall 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-device.
What Happened
ARROW INTERNATIONAL, LLC initiated a voluntary recall of certain hemodialysis kits after discovering that included lidocaine, bupivacaine, and 0.9% sodium chloride were part of a supplier recall due to quality issues and 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 HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM with REF AK-12122-F. A total of 1,945 units are affected. Affected lots include: 33F24B0184, 33F24D0076, 33F24F0321, 33F24G0345, 33F24K0111, 33F25A0474, 33F25C0915, 33F25E0061, 33F25E0924, 33F25J0832, 33F25L0404, 33F26B0552, 33F24A0102. UDI-DI numbers include 10801902197129, 10801902193275, 10801902197129, and 10801902168464. The recall number is Z-2381-2026. 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.
What You Should Do
Consumers and healthcare providers should follow guidance from the recalling firm regarding the affected kits.
Why This Matters
This Class I recall involves a risk of serious or life-threatening injuries due to potential compromised sterility in included injectable products.
Source
FDA recall Z-2381-2026
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 (1,465 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.