Arrow International Recalls CVC Kits and Access Trays
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ARROW INTERNATIONAL, LLC is recalling 1,061,069 units of various central venous catheter kits and access trays distributed nationwide due to included drugs 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 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, MedicalDevices.
What Happened
ARROW INTERNATIONAL, LLC initiated a voluntary recall of multiple central venous catheter (CVC) kits and access trays after determining that lidocaine, bupivacaine, and 0.9% sodium chloride from a supplier 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 1,061,069 units of numerous products including ACCESS TRAY/ASK-04001-JHH, ACCESS TRAY/ASK-04001-LMDTG, PI CVC KIT: 3 LUMEN 7 FR X 6 IN (16 CM)/ASK-12703-PSPH1, 3L CVC KIT: 7 FR X 16 CM/ASK-12703-WMC2, and dozens of additional models such as ASK-15703-LMDT1, ASK-24301-JHH1, CDC-24306-1A, ASK-42703-ACH, ASK-45703-ACH, and many others with specific REF numbers and lot codes listed in FDA recall Z-2384-2026. Products were distributed nationwide including to 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 should follow instructions provided in the firm's notification letter regarding the affected kits and sets.
Why This Matters
This Class I recall involves over one million units of medical devices where compromised sterility or drug ineffectiveness could result in serious or life-threatening injuries.
Source
FDA recall number Z-2384-2026. 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 (1,570 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.