Arrow International Recalls PICC Access Tray (Z-2395-2026)
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 360 units of PICC Access Tray kits distributed nationwide after including recalled drugs from a supplier with sterility concerns.
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 PICC Access Trays after including Lidocaine, Bupivacaine, and 0.9% sodium chloride from a supplier found to have quality issues. The supplier recall involved limited reports of drug ineffectiveness, and compromised sterility of water-based injectable products could lead to serious or life-threatening injuries.
Which Products Are Affected
- Product: PICC ACCESS TRAY/ASK-04001-CG1
- REF/UDI-DI/Lots: ASK-04001-CG1/10801902193275/33F25C0224, 33F25D0647, 33F25G0390, 33F25J0348
- Quantity: 360 units
- Distribution: US 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, PR
- Recall Number: Z-2395-2026
- Classification: Class I
- Initiation Date: April 21, 2026
What You Should Do
Consumers and healthcare facilities should follow the recalling firm's instructions regarding the affected kits and sets.
Why This Matters
This Class I recall addresses a potential sterility issue in injectable components that could result in serious or life-threatening injuries.
Source
FDA recall Z-2395-2026, 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 (1,276 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.