Mahurkar Dialysis Catheters Recalled for Center Lumen Obstruction
Covidien is recalling 1,099 MAHURKAR dialysis catheters worldwide due to excessive silicone lubricant that can block the center lumen, potentially delaying treatment.
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: FDA Class I classification requires a minimum rating of Severe (4). The obstruction can delay critical dialysis treatment and cause serious complications including embolism and thrombosis.
Plain-English summary
Covidien LP is recalling 1,099 MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter units (REF: 8888104003HP). The affected lot numbers are 2131200173, 2133700237, 2200400273, and 2200400290. These catheters were distributed nationwide and internationally.
The center lumen of these catheters was found to have an obstruction caused by excessive MDX, a silicone-based lubricant used to coat the catheter tip. This excessive buildup or uncured lubricant may dislodge or partially obstruct the catheter.
A fully or partially obstructed catheter can delay treatment or reduce blood flow during dialysis. If the silicone lubricant particles dislodge, they may enter the bloodstream and cause serious complications including hemolysis (destruction of red blood cells), embolism (blockage from debris), or thrombosis (blood clots). Dialysis centers should immediately stop using the affected lot numbers and contact Covidien for replacement units.
The recalled product
- Product
- MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP
- Manufacturer
- Covidien LP
- Affected units
- 1,099
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 (1)
- GTIN: 20884521128054 LOT Numbers: 2131200173 2133700237 2200400273 2200400290
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Covidien LP 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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