Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    REF/UDI-DI/Lots: CS-15242-VSP/30801902195273/33F23C0870, 33F23D0857, 33F23F0719, 33F23K0182, 33F24A0265, 33F24C0062, 33F24D1000, 33F24D1039, 33F24E0803, 33F24H0038, 33F24H0261, 33F24K0505, 33F24M0039, 33F24M0218, 33F25A0141, 33F25C0657, 33F25D0125, 33F25E0305, 33F25E0429, 33F25E0430, 33F25E1131, 33F25F0042, 33F25G0070, 33F25H0295, 33F25H0366, 33F25H0674, 33F25J1015; CS-15282-VSP/30801902195518/33F23C0866, 33F23D0854, 33F23E0572, 33F23F0594, 33F23G0540, 33F23J0544, 33F23K0174, 33F23L0950, 33F24B0010, 33F24C0060, 33F24D0993, 33F24D1040, 33F24E0268, 33F24E0809, 33F24F0155, 33F24J0037, 33F24M0007, 33F24M0040, 33F24M0165, 33F24M0217, 33F25A0406, 33F25B0269, 33F25C0021, 33F25C0045, 33F25C0642, 33F25D0013, 33F25D0713, 33F25F0249, 33F25H0296, 33F25J0051; CS-15322-VSP/20801902195184/33F23C0869, 33F23D0862, 33F23F0723, 33F23H0985, 33F24A0272, 33F24C0066, 33F24E0813, 33F24G0170, 33F24G0185, 33F24H0256, 33F24J0040, 33F24L0183, 33F24M0222, 33F25A0426, 33F25C0022, 33F25C0593, 33F25E1082, 33F25G0024, 33F25H0297; CS-15362-VSP/30801902195525/33F23C0875, 33F23G0546, 33F23K0195, 33F24E0186, 33F24H0039, 33F24L0201, 33F24M0235, 33F25C0647, 33F25E0326, 33F25G0058, 33F25J0043; CS-15552-VSP/30801902195198/33F23G0552, 33F23H0987, 33F23L0961, 33F24C0070, 33F24E0820, 33F24H0257, 33F24L0068, 33F24M0227, 33F25C0654, 33F25E0432; CSD-15242-SP/20801902096610/33F24A0303, 33F25C0688; CSD-15282-SP/20801902096634/33F23K1087, 33F24A0297; CS-15242-SPM/10801902193527/33F23D0867, 33F23K0192, 33F24A0288, 33F24E0802, 33F24M0244, 33F25C0669, 33F25E0338, 33F25G0586; CS-15282-SPM/10801902193688/33F23C0872, 33F23D0864, 33F23G0539, 33F23L0949, 33F24A0278, 33F24C0075, 33F24E0808, 33F24H0254, 33F24J0036, 33F24L1166, 33F24M0233, 33F25A0413, 33F25C0666, 33F25H0824; CS-15322-SPM/30801902193538/33F23D0865, 33F23H1010, 33F23L0955, 33F24E0812, 33F25C0682, 33F25E0335; CS-15362-SPM/20801902193548/33F24G0062
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ARROW INTERNATIONAL, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM

Product Codes/Lot Numbers:

REF/UDI-DI/Lots: CS-15242-VSP/30801902195273/33F23C0870, 33F23D0857, 33F23F0719, 33F23K0182, 33F24A0265, 33F24C0062, 33F24D1000, 33F24D1039, 33F24E0803, 33F24H0038, 33F24H0261, 33F24K0505, 33F24M0039, 33F24M0218, 33F25A0141, 33F25C0657, 33F25D0125, 33F25E0305, 33F25E0429, 33F25E0430, 33F25E1131, 33F25F0042, 33F25G0070, 33F25H0295, 33F25H0366, 33F25H0674, 33F25J1015; CS-15282-VSP/30801902195518/33F23C0866, 33F23D0854, 33F23E0572, 33F23F0594, 33F23G0540, 33F23J0544, 33F23K0174, 33F23L0950, 33F24B0010, 33F24C0060, 33F24D0993, 33F24D1040, 33F24E0268, 33F24E0809, 33F24F0155, 33F24J0037, 33F24M0007, 33F24M0040, 33F24M0165, 33F24M0217, 33F25A0406, 33F25B0269, 33F25C0021, 33F25C0045, 33F25C0642, 33F25D0013, 33F25D0713, 33F25F0249, 33F25H0296, 33F25J0051; CS-15322-VSP/20801902195184/33F23C0869, 33F23D0862, 33F23F0723, 33F23H0985, 33F24A0272, 33F24C0066, 33F24E0813, 33F24G0170, 33F24G0185, 33F24H0256, 33F24J0040, 33F24L0183, 33F24M0222, 33F25A0426, 33F25C0022, 33F25C0593, 33F25E1082, 33F25G0024, 33F25H0297; CS-15362-VSP/30801902195525/33F23C0875, 33F23G0546, 33F23K0195, 33F24E0186, 33F24H0039, 33F24L0201, 33F24M0235, 33F25C0647, 33F25E0326, 33F25G0058, 33F25J0043; CS-15552-VSP/30801902195198/33F23G0552, 33F23H0987, 33F23L0961, 33F24C0070, 33F24E0820, 33F24H0257, 33F24L0068, 33F24M0227, 33F25C0654, 33F25E0432; CSD-15242-SP/20801902096610/33F24A0303, 33F25C0688; CSD-15282-SP/20801902096634/33F23K1087, 33F24A0297; CS-15242-SPM/10801902193527/33F23D0867, 33F23K0192, 33F24A0288, 33F24E0802, 33F24M0244, 33F25C0669, 33F25E0338, 33F25G0586; CS-15282-SPM/10801902193688/33F23C0872, 33F23D0864, 33F23G0539, 33F23L0949, 33F24A0278, 33F24C0075, 33F24E0808, 33F24H0254, 33F24J0036, 33F24L1166, 33F24M0233, 33F25A0413, 33F25C0666, 33F25H0824; CS-15322-SPM/30801902193538/33F23D0865, 33F23H1010, 33F23L0955, 33F24E0812, 33F25C0682, 33F25E0335; CS-15362-SPM/20801902193548/33F24G0062

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2158-2026

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Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: 19 GA/AK-05501; EPIDURAL CATHETERIZATION KIT/AK-05502; EPIDURAL CATHETERIZATION KIT/AK-05502D; EPIDURAL CATHETERIZATION KIT/AK-05503; EPIDURAL CATHETERIZATION KIT/AK-05503-L; SPINAL ANES/EPIDURAL CATH KIT/AK-05560; SPINAL ANES/EPIDURAL CATH KIT/ASK-02520-SBMC1; EPIDURAL CATHETERIZATION KIT/ASK-05400-BW1; EPIDURAL CATHETERIZATION KIT/ASK-05400-GH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05401-LMC; EPIDURAL CATHETERIZATION KIT/ASK-05401-NM; SPINAL ANES/EPIDURAL CATH KIT/ASK-05500-BID1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-JHH1; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-MCV1; EPIDURAL CATHETER KIT: 19GA X 90CM ASK-05500-MVH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-UMC; 19 GA X 35.5 IN EPIDURAL CATHETER KIT/ASK-05502-MLH; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-JMH1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-MKD2; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-OM1; EPIDURAL CATHETERIZATION KIT/ASK-17019-SM; EPIDURAL CATHETERIZATION KIT/BP-05501; EPIDURAL CATHETERIZATION KIT/CK-05401; EPIDURAL CATHETERIZATION KIT/HS-05501; EPIDURAL CATHETERIZATION KIT/MM-05501; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TK; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKD; EPIDURAL CATHETERIZATION KIT: 19 GA/MP-17019-TKL; EPIDURAL CATHETERIZATION KIT/MSO-05401-JMH; EPIDURAL CATHETERIZATION KIT/NM-05401; EPIDURAL CATHETERIZATION KIT/SJ-05501; EPIDURAL CATHETERIZATION KIT/SM-05401; EPIDURAL CATHETER KIT: 19 GA X 90 CM/TM-05401; EPIDURAL CATHETERIZATION KIT/TM-05502; SPINAL ANES/EPIDURAL CATH KIT/UI-05502; SPINAL ANES/EPIDURAL CATH KIT: 19 GA/ASK-05400-SHM; EPIDURAL CATH KIT: 19 GA/ASK-05400-UOM; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05500-MR; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-05500-TM; EPIDURAL CATHETERIZATION KIT/ASK-05501-BHL1; EPIDURAL CATHETERIZATION KIT/ASK-05501-GH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-SM; EPIDURAL CATHETERIZATION KIT/ASK-05502-BSM; EPIDURAL CATHETERIZATION KIT/ASK-05502-MGH1; EPIDURAL CATHETERIZATION KIT/ASK-05503-BWB1; EPIDURAL CATHETERIZATION KIT/ASK-05503-HMH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-SPH; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05503-UPM1; SPINAL ANES/EPIDURAL CATH KIT/ASK-05560-UCI2; EPIDURAL CATHETERIZATION KIT: 19 GA/ASK-17019-UMP; EPIDURAL CATHETERIZATION KIT/MH-05503-1; EPIDURAL CATHETERIZATION KIT/ASK-05401-VB2; Epidural Catheterization Kit: 19GA/ASK-05500-SC1; Epidural Catheterization Kit: 19GA/ASK-05500-SC3; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-AFH1; EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05501-BMC; EPIDURAL CATHETERIZATION KIT/ASK-05502-NY; EPIDURAL CATHETERIZATION KIT/ASK-17019-RMH

ARROW INTERNATIONAL

Class I - Dangerous

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.

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Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK-12123-UOC1, AHDC KIT: 3-L 12 FR X 16 CM/ASK-12123-UPM, AHDC KIT: 3L 12 FR X 20 CM/ASK-15123-UOC1, AHDC KIT: 3-L 12 FR X 20 CM/ASK-15123-UPM, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-P1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XP1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPCN1A, AHDC KIT: 3-L 12 FR X 16 CM/CDC-12123-XPN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-P1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPCN1A, AHDC KIT: 3-L 12 FR X 20 CM/CDC-15123-XPN1A, AHDC KIT: 3-L 12 FR X 25 CM/CDC-16123-XPCN1A, HEMODIALYSIS KIT 2L: 12 FR X 20CM AGB/AK-25122-CDC, HEMODIALYSIS KIT: 2-LUMEN 14 FR X 20 CM/AK-25142-F, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM1, HEMODIALYSIS KIT: 2L 12 FR X 6 IN/ASK-22122-MM2, AHDC KIT: 2L 14 FR X 15 CM/ASK-22142-UOC1, AHDC AGB KIT: 2-L 14 FR X 15 CM/ASK-22142-UPM, HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UNC1, AHDC KIT: 2L 14 FR X 20 CM/ASK-25142-UOC1, AHDC AGB KIT: 2L 14 FR X 20 CM/ASK-25142-UPM, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/ASK-26142-UNC1, HEMODIALYSIS KIT: 2LUMEN 12 FR X 16 CM/AU-22122-F, HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-XN1A-U, HEMODIALYSIS KIT 2L: 14 FR X 15 CM AGB/CDC-22142-1A, HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-XC1A, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-XN1A-C, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XCN1A-U, AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-XN1A-U, HEMODIALYSIS KIT: 2L 12 FR X 13 CM AGB/CDC-23122-XU1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-X1A, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A, AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-XCN1A-U, AHDC AGB KIT: 2-L 12 FR X 20 CM/CDC-25122-XN1A, HEMODIALYSIS KIT: 2L 12 FR X 20 CM AGB/CDC-25122-XU1A, HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/CDC-25142-1A, HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB/CDC-25142-XC1A, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XCN1A-C, AHDC AGB KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A, AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-XN1A-C, HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XCN1A, AHDC AGB KIT: 2-L 12 FR X 25 CM/CDC-26122-XN1A, HEMODIALYSIS KIT 2L: 14 FR X 25 CM AGB/CDC-26142-1A, HEMODIALYSIS KIT: 2L 14 FR X 25 CM AGB/CDC-26142-X1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XCN1A, AHDC AGB KIT: 2-L 14 FR X 25 CM/CDC-26142-XN1A, HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-25122-F, AHDC AGB KIT: 2-L 12 FR X 16 CM/CDC-22122-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 16 CM/CDC-22123-XCN1A, LBCVC AGB KIT: 3-L 12 FR X 20 CM/CDC-25123-XCN1A, LBCVC AGB KIT:3-L 12 FR X 20 CM/CDC-25123-XN1A

ARROW INTERNATIONAL

Class I - Dangerous

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.

Apr 21, 2026 Other Medical Devices Nationwide View Details →