Arrow International Hemodialysis Kits Recall
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ARROW INTERNATIONAL, LLC is recalling 62,719 hemodialysis and AHDC kits distributed nationwide after including drugs subject to a supplier recall that may compromise sterility.
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 multiple hemodialysis kits and AHDC kits after determining that lidocaine, bupivacaine, and 0.9% sodium chloride from a supplier recall were included. 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 62,719 units of various kits including HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, and dozens of additional models such as AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-1A, and others listed under recall number Z-2388-2026. Affected lots are identified by specific REF/Material and UDI-DI numbers with batch codes beginning with 33F. The products were 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.
What You Should Do
Consumers and healthcare facilities should follow instructions provided by the recalling firm regarding the affected kits.
Why This Matters
This is a Class I recall, indicating the potential for serious or life-threatening injuries if sterility is compromised.
Source
FDA recall number Z-2388-2026, 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 (1,517 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.