Recall archive / FDA device enforcement
MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611 — FDA record Z-2386-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 28, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
- Reason
- 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
- Classification
- Class I
- Recalling firm
- Covidien LP
- Quantity
- 69987 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2386-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN:10884521006782 / 20884521006789 LOT Numbers: Lot Number 1907700087 1915800147 1915800149 1924500084 1924500085 1924500087 1924500088 1933000070 1933000071 1933000073 1934300131 1934300134 1934300135 1934300136 1934400128 1934400174 1935100073 1935100074 1935100085 1935100086 1935100087 1935100088 2000700065 2000700066 2002100112 2002100114 2002900106 2003900122 2003900123 2005500062 2005500064 2006500075 2007800071 2007800072 2007800073 2009200094 2009300094 2009300095 2009300096 2010800205 2011300096 2011300098 2011300099 2017400084 2018800018 2018800021 2018800023 2019500195 2019500198 2029700145 2032300067 2032800039 2032800040 2033100068 2033100069 2104100115 2122900118 2122900159 2122900161 2122900195 2122900217 2122900276 2122900277 2123000092 2123000115 2124600186 2124600190 2127300095 2131200168 2131200172 2131200175 2131200178 2131200179 2133700137 2133700138 2133700140 2230400265 2230400277 2230400278 2234800082 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide - Worldwide Distribution Foreign: Argentina Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Canada Cayman Islands China Costa Rica Czech Republic Denmark Dominican Republic Finland France French Polynesia Germany Greece Hungary India Iran, Islamic Republic Of Ireland Italy Kuwait Malaysia Maldives Mauritius Mexico Nepal Netherlands New Caledonia Nicaragua Norway Philippines Poland Portugal Puerto Rico Saudi Arabia Singapore Slovakia South Africa Spain Sri Lanka Sweden Switzerland Thailand Turkey United Arab Emirates United Kingdom
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 23, 2023
- Recall initiation date
- Jun 28, 2023
- Center classification date
- Aug 11, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.