Cannon II Plus Hemodialysis Catheter Recall Due to Sheath Introducer Defect
Arrow International is recalling Cannon II Plus Hemodialysis Catheters due to a defective sheath introducer that may not split properly, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, and tissue injury.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a medical device. Class I recalls are by definition likely to cause serious adverse health consequences or death. The stated hazards include bleeding, hematoma, tissue injury, and vessel wall injury, which constitute significant injury risk.
Plain-English summary
Arrow International, LLC is recalling Cannon II Plus Hemodialysis Catheters and Cannon II Plus Hemodialysis Catheters with Arrow Simplicity Micro-Introducer. The recall affects approximately 34,568 units distributed worldwide, including throughout the United States and to countries in Europe, Asia, Africa, South America, and the Middle East.
The recall is due to a defective dual-valved splittable sheath introducer included in the hemodialysis kits and sets. The sheath introducer may not split as intended during use. This defect can result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, and vessel wall injury.
Patients using these catheters should contact their healthcare provider. Healthcare facilities should review their inventory and follow the manufacturer's instructions for appropriate action regarding affected units.
The recalled product
- Product
- 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…
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Affected units
- 34,568
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Part of a larger recall action
This product is one of 4 recalled by ARROW INTERNATIONAL, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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