FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International PICC kits and stylets recalled for compromised sterility and drug ineffectiveness

OTHERNationwide distributionMedical devices

What this means

Arrow International recalled several PICC (peripherally inserted central catheter) kits and stylets because they contain injectable medications from a supplier with quality issues. The medications—lidocaine, bupivacaine, and saline—may be ineffective or contaminated, which could cause serious injury if used.

  • Check if you have any affected PICC kits or stylets listed in this recall (lot numbers and model numbers available on FDA.gov).
  • Do not use affected kits; contact your healthcare provider or hospital for replacements.
  • Report any adverse effects or injuries to the FDA MedWatch program or your healthcare provider.
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The agency's original wording
Hazard

Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution including in 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, PR.
Affected count
11,358
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR x 55CM TCG/DLX-45563-VPSC; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHD1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UCHS1; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-DU13; ARROW(R) VPS(R) ACCESS KIT/ASK-04001-UNHS1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2367-2026

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