Recall Z-2156-2026 ยท MSD Catheter, Hemodialysis, Implanted
ARROW INTERNATIONAL, LLC
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
| Date | May 13, 2026 (initiated Apr 10, 2026) |
| Status | Open, Classified |
| Reason | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury. |
| Root cause | Nonconforming Material/Component |
| Action | On 4/10/2026, recall notices were mailed to customers who were informed of the following Arrow International LLC is recalling product due to the Merit Medical Systems, Inc. recall of the Merit 16F Dual-Valved Splitable Sheath Introducer component, which is included in impacted Arrow Hemodialysis Kits & Sets. Customers were asked to do the following: 1) Users should cease use and distribution of affected product and immediately quarantine the affected product. 2) Complete and return the Acknowledgement Form, see link: https://fca.myteleflex.com/en/recall/000605 3) This notice should be passed |
| Quantity | 285 |
| Distribution | Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111117 | CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC... Teleflexmedical, Inc., Jun 30, 2011 |