Recall Z-2378-2026 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
ARROW INTERNATIONAL, LLC
Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT: 1L 4.5FR 40CM/CDC-44041-HPK1A; AGBA PI PICC KIT 2-LUMEN: 5.5 FR X 40CM/CDC-44052-HPK1A; AGBA PICC/DELTA FG: 2-L 5.5 FR X
| Date | Jun 13, 2026 (initiated Apr 21, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 4/21/2026, correction notices (Firm Event Number: EIF-000608, lidocaine and bupivacaine) were mailed to customers who were asked to do the following: Arrow International LLC is voluntarily recalling product due to the Huons Co. Ltd. recall of Lidocaine and Bupivacaine, which is included in impacted Arrow Kits & Sets. Medical facilities 1. Provide this correction notice to all persons who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 2. Check your inventory for product within the scope of this Medical Device No |
| Quantity | 3,481 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042126 | PICC Arrow Intl., Inc., Aug 27, 2004 |
| K112896 | ARRW EVOLUTION Arrow International (Subsidiary of Teleflex Inc.), May 10, 2012 |
| K113277 | ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS Arrow International, Inc., Jun 21, 2012 |
| K122545 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.), Sep 20, 2012 |
| K130876 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International, Inc., Apr 26, 2013 |
| K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Jan 28, 2016 |