Arrow International Recalls CVC 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 35,540 CVC kits nationwide due to potential sterility issues from included drugs subject to a supplier recall.
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, medical-devices.
What Happened
Arrow International, LLC initiated a voluntary recall of certain CVC 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 35,540 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:
- CVC KIT: 16 GA X 8IN / AK-04210
- CVC KIT: 1-L 16 GA X 8IN (20 CM) / AK-04300
- CVC KIT: 14 GA X 6 IN / CK-04711
Specific lot and UDI information is listed under recall number Z-2396-2026. This is a Class I recall.
What You Should Do
Consumers and healthcare providers should stop using the affected kits and follow instructions from the recalling firm or FDA regarding the ongoing recall.
Why This Matters
This Class I recall involves products that could cause serious or life-threatening injuries if sterility is compromised.
Source
FDA recall Z-2396-2026, Arrow International, LLC, Morrisville, NC.
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 (1,327 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.