Arrow International Recalls Peritoneal Lavage Cath Kit

Source: FDA · United States

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 is recalling 7,560 Peritoneal Lavage Cath Kits due to included drugs from a supplier with quality issues that may compromise sterility.

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 the PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 after determining that Lidocaine, Bupivacaine, and 0.9% sodium chloride from a supplier with quality issues were included in the kits. The supplier recall involved limited reports of drug ineffectiveness, and compromised sterility of a water-based injectable product could lead to serious or life-threatening injuries.

Which Products Are Affected

The recall affects 7,560 units of PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 distributed nationwide in the United States, including the states of 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. Affected REF and lots include AK-09000 with UDI-DI codes and batch numbers: 30801902121722, 10801902193275, 20801902121756/33F24B0178, 33F24C0097, 33F24E0336, 33F24F0311, 33F24G0335, 33F24K0101, 33F24L0795, 33F25E0919, 33F25G0467, 33F25G0758, 33F25H0722, 33F25J0468, 33F25L0463, 33F26A0389, 33F24A0368. This is FDA Class I recall number Z-2380-2026.

What You Should Do

Consumers should stop using affected products and contact the recalling firm for further instructions regarding the recall.

Why This Matters

This Class I recall involves potential for serious or life-threatening injuries from compromised sterility in a medical device kit distributed across the United States.

Source

FDA recall Z-2380-2026, initiated 2026-04-21.

Original source: FDA Official Notice ↗

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.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Arrow International is recalling 7,560 Peritoneal Lavage Cath Kits due to included drugs from a supplier with quality issues that may compromise sterility.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.