MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
Enforcement
- Recall Number
- Z-2385-2023
- Event ID
- 92660
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 23, 2023
- Initiation Date
- June 28, 2023
- Classification Date
- August 11, 2023
- Address
- 15 Hampshire St, Mansfield, MA, 02048-1113, United States
Description
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
GTIN: 20884521128139 LOT Numbers: 2017400081 2028300087 2113300282 2133700046 2227800105
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2685 units