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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Covidien LP: 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/em

Agency Publication Date: August 11, 2023
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Affected Products

Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP

GTIN:20884521127897 LOT Numbers: 2133600127 2133700049 2200400180

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP

GTIN: 20884521127965 LOT Numbers: 2133600171 2133600172 2133700047 2133700048 2133700060 2200400110 2204000236 2230400213 2230400214 2233400068

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP

GTIN: 20884521127972 LOT Numbers: 2130900104 2133600083 2133600160 2133600165 2226500171 2226500173 2227800101 2227800104 2227800109 2230400208

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP

GTIN: 20884521127989 LOT Numbers: 2130900107 2133700059

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP

GTIN: 20884521127996 LOT Numbers: 2204000239 2227800110

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP

GTIN: 20884521128009 LOT Numbers: 2200400154

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP

GTIN: 0884521128010 LOT Numbers: 2133700228

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP

GTIN: 20884521128023 LOT Numbers: 2133700232 2133700247 2133700248

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP

GTIN:20884521128047 LOT Numbers: 2133700227

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP

GTIN: 20884521128054 LOT Numbers: 2131200173 2133700237 2200400273 2200400290

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP

GTIN: 20884521128061 LOT Numbers: 2200400292

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629

GTIN: 20884521057019 LOT Numbers: 1921300069 2227800100

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP

GTIN: 10884521128071, 20884521128078 LOT Numbers: 1926100313 1926100314 1926100315 1933000064 2034900046 2102200138 2107700127 2113300296 2119400212 2123000099 2130800131 2203300174 2230400227

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637

GTIN: 20884521057026 LOT Numbers: 2119400209 2122900117 2124600187

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP

GTIN: 10884521128088, 20884521128085 LOT Numbers: Lot Number 1907700088 2015100039 2019500217 2107700128 2113300287

Lot Numbers:
Numbers
Number
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP

GTIN: 20884521128108 LOT Numbers: 2018800014 2023400145 2027200276 2119400215 2130800064 2201000047

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP

GTIN: 20884521128115 LOT Numbers: 2018800011 2203900129

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603

GTIN: 10884521006768/ 20884521006765 LOT Numbers: 1907700093 1908400296 1914400157 1914400158 1914800241 1914800242 1914800243 1915800144 1915800145 1916500157 1920700126 1921100198 1921100199 1921100201 1921300056 1921300057 1928700083 1932300211 2000700063 2000700064 2001400084 2002100115 2002900099 2002900103 2002900104 2005700211 2005700212 2007800069 2007800070 2007800088 2009000047 2009400127 2010800201 2010800203 2010800204 2010800206 2010800207 2015100040 2015100043 2017400082 2019500192 2131200161 2131200162 2131200163 2227800106 2227800111 2227800112 2227800114 2227800115 2230400303 2230400304 2232700203

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP

GTIN: 20884521128139 LOT Numbers: 2017400081 2028300087 2113300282 2133700046 2227800105

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611

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

Lot Numbers:
Numbers
Number
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP

GTIN: 10884521128149 / 20884521128146 LOT Numbers: 1908400297 1908400298 1908400299 1908800136 1920500260 1924500090 1926100317 1926100318 1926800467 2018800025 2018800044 2018800045 2018800046 2019500187 2020500079 2021000109 2021000110 2021000111 2023400151 2102200137 2102600093 2104100085 2113000069 2113300288 2116200130 2116500175 2119400217 2119400219 2131200183 2203300166 2203300169 2203300170 2203300173 2203300175 2232700163 2232700197 2232700207 2234800070

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629

GTIN: 10884521006799 LOT Numbers: 2009400128 2113300290 2116500142 2116500176 2119400221 2119400227 2122900119 2122900127 2122900216 2122900231 2127300111 2127300113

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP

GTIN: 0884521128163/ 20884521128160 LOT Numbers: Lot Number 1828200086 1925300170 1925300171 2018800013 2018800024 2018800043 2019500199 2019500200 2019500222 2021000106 2021000107 2029600102 2029600103 2116600083 2131200176 2133700166 2227800108 2230400250 2230400251 2234800071

Lot Numbers:
Numbers
Number
Product: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637

GTIN: 10884521006829/ 20884521006826 LOT Numbers: 2124600191 2127300121

Lot Numbers:
Numbers
Product: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP

GTIN: 10884521128187 / 20884521128184 LOT Numbers: 1916500156 2017400085 2028300088 2102600094 2104600149 2107700145 2113100057 2119400230 2123000100 2133700164

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92660
Status: Active
Manufacturer: Covidien LP
Manufactured In: United States
Units Affected: 25 products (2370 units; 6615; 5373 units; 1325 units; 1875 units; 685 units; 299 units; 299 units; 271 units; 1099 units; 519 units; 655 units; 7293 units; 775 units; 2425 units; 600 units; 295 units; 45880 units; 2685 units; 69987 units; 32125 units; 6949 units; 15209 units; 647 units; 3965 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.