NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SF...
Reason for Recall / Hazard
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.
Product Description & Identification
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X; NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM
Affected Products
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X; NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM
Additional Source Details
| Field | Value |
|---|---|
| City | Morrisville |
| State | NC |
| Event id | 98745 |
| Address 1 | 3015 Carrington Mill Blvd |
| Code info | REF/UDI-DI/Lots: AC-15192-SFX/30801902197758/AC-15192-SFX; AC-15232-SFX/00801902095909/33F23H1018; CS-15192-SFX/30801902195297/33F23E0575, 33F23G0530, 33F23K0187, 33F23K1104, 33F23L0929, 33F24A0275, 33F24C0068, 33F24D1012, 33F25C0020, 33F25E1083, 33F25G0636, 33F25H0292, 33F25H0790, 33F25L0038; CS-15232-SFX/30801902195549/33F23E0576, 33F23G0534, 33F23L0936, 33F24A0279, 33F24C0067, 33F24D1006, 33F24E0684, 33F24H0258, 33F24J0033, 33F24J0085, 33F24J0342, 33F24L0056, 33F24M0231, 33F25A0405, 33F25C0036, 33F25C0664, 33F25D0739, 33F25E0433, 33F25G0716, 33F25H0248; CS-15272-SFX/10801902195217/33F23B0321, 33F23D0859, 33F23H0500, 33F23K0177, 33F23L0943, 33F24A0280, 33F24C0083, 33F24H0042, 33F24H0260, 33F24J0022, 33F24J0038, 33F24J0088, 33F24L0177, 33F25C0028, 33F25E1090, 33F25F0301, 33F25F0514; CS-15312-SFX/30801902197529/33F23G0541, 33F23H0984, 33F23L0951, 33F24A0283; CS-15422-SFX/30801902195327/33F23K0179, 33F23L0956, 33F24A0290, 33F24E0814; CS-15502-SFX/30801902195563/33F23L0959, 33F24A0286,... [TRUNCATED] |
| Postal code | 27560-5437 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 19,687 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260410 |
| Center classification date | 20260513 |
Overview
- Recalling FirmARROW INTERNATIONAL, LLC
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide 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, UA, VN, ZA, ZM, and ZW