Medtronic Recalls Unsterilized Acute Dual Lumen Dialysis Catheters
Medtronic is voluntarily recalling one lot of MAHURKAR Elite Acute Dual Lumen Dialysis Catheters because they were distributed without being sterilized.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that was distributed without being sterilized, which poses a risk of harm (infection) even though no injuries or illnesses have been reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Minimally Invasive Therapies Group is voluntarily recalling one lot of its MAHURKAR Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. The specific product number is 8888222316, and the affected lot number is 1717900160.
The recall was initiated after Medtronic received notification from a supplier that the production lot was inadvertently shipped to Medtronic and distributed without being sterilized. The source text does not specify the number of units affected or the specific geographic distribution beyond the United States.
Consumers and healthcare facilities should check their inventory for this specific lot number and stop using the product if it matches the recall details. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the use of these unsterilized catheters.
The recalled product
- Product
- MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.
- Manufacturer
- Medtronic Minimally Invasive Therapies Group
- Hazard
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)
- UDI: 10884521126473/20884521126470 Lot: 1717900160.
Distribution
Distribution scope not specified by the agency.
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