Arrow International Recalls PICC Kits Over Supplier Drug Quality Issues
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ARROW INTERNATIONAL, LLC is recalling 37,738 units of various PICC kits distributed nationwide after including drugs subject to a supplier recall with potential quality and sterility 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, medical-devices.
What Happened
ARROW INTERNATIONAL, LLC initiated a voluntary recall of multiple peripherally inserted central catheter (PICC) kits after determining that lidocaine, bupivacaine, and 0.9% sodium chloride included in the kits were 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 covers 37,738 units of the following products with specific REF numbers and lot/batch codes: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS; AGBA PICC/DELTA: 2L 5.5 FR X 50 CM/ASK-45052-NS; AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM/ASK-45541-MHBV; PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS/ASK-45552-RH; AGBA PICC NaviCurve: 2L 5.5FR x 55CM BP/DLX-45552-CURVB; AGBA PICC NaviCurve: 2L 5.5FR x 55CM TCG/DLX-45552-CURVC; AGBA PICC: 2L 5.5FR x 55CM w Biopatch/DLX-45552-HPKB; AGBA PICC NaviCurve: 3L 6FR x 55CM BP/DLX-45563-CURVB; PI PICC KIT: 4 FR X 50 CM/ASK-35041-NH; PI PICC KIT: 2-L 5 FR X 50 CM/ASK-35052-NH; PI PICC G4 Stylet: 1L 4FR x 55CM w CHG/DLX-35541-VPSC; PI PICC NaviCurve: 2L 5FR x 55CM w BP/DLX-35552-CURVB; PI PICC NaviCurve: 3L 6FR x 55CM w BP/DLX-35563-CURVB; PI PICC G4 Stylet: 3L 6FR x 55CM w BP/DLX-35563-VPSB; AGBA PI PICC KIT: 2L 5.5 FR X 55CM/CDC-45552-HPK1A; PI AGBA PICC KIT: 3-L 6 FR X 55 CM/CDC-45563-HPK1A; PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI1; PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-VFH1; PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI1; PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-VFH1; PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS/ASK-45563-UWH1; AGBA PICC NaviCurve: 1L 4.5FR x 55CM BP/DLX-45541-CURVB; AGBA PICC NaviCurve: 1L 4.5FR x 55CM TCG/DLX-45541-CURVC; AGBA PICC G4 Stylet: 1L 4.5FR x 55CM TCG/DLX-45541-VPSC; AGBA PICC G4 Stylet: 2L 5.5FR x 55CM BP/DLX-45552-VPSB; AGBA PICC G4 Stylet: 2L 5.5FR x 55CM TCG/DLX-45552-VPSC; PI PICC:1L 4FR X 50CM PRELOAD VPS STYLET/CDC-35041-VPS; PICC KIT: 3 FR X 55 CM/CDC-05531-PK1A. Affected lots are identified by specific UDI-DI and batch codes listed in FDA recall Z-2370-2026. Distribution was 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.
What You Should Do
The recall is voluntary and firm-initiated. Customers should not use affected products and should contact ARROW INTERNATIONAL, LLC regarding returns.
Why This Matters
This is a Class I recall, indicating a reasonable probability that use of the affected devices could lead to serious adverse health consequences or death.
Source
FDA recall number Z-2370-2026, report date 20260624.
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 (2,841 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.