Arrow International SAC Kits Recall
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 certain SAC Kits containing lidocaine, bupivacaine, and 0.9% sodium chloride due to potential sterility issues from a supplier.
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, Devices.
What Happened
ARROW INTERNATIONAL, LLC initiated a voluntary recall of SAC Kits that included lidocaine, bupivacaine, and 0.9% sodium chloride subject to a supplier recall. 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 affects the following products distributed nationwide in 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:
- SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B, REF SAC-01218-B, UDI-DI 10801902225303, Lot 33F26C0515
- SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C, REF SAC-01218-C, UDI-DI 10801902225273, Lot 33F26C0517
- SAC KIT: 18 GA X 16CM W BIO/SAC-01618-B, REF SAC-01618-B, UDI-DI 10801902225310, Lot 33F26C0518 Recall Number: Z-2390-2026. Classification: Class I. Product quantity reported as 0.
What You Should Do
Consumers should refer to the recalling firm for return or refund instructions.
Why This Matters
This Class I recall involves potential sterility compromise in injectable products that could lead to serious or life-threatening injuries.
Source
FDA recall Z-2390-2026, Event ID 98793.
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 (1,410 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.