MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use
Medical device recall Z-0877-2023. Published in FDA’s Enforcement Report on Jan 18, 2023.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 18, 2023. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- 359,730 (23,003 US; 336,727 OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Curved, Kit - Model No. 8888135133; 13.5cm, Straight Extensions, IC Tray, Model No. 8888135134; 16cm, Straight Extensions, Kit - Model No. 8888135161; 16cm, Curved Extensions, Kit - Model No. 8888135162; 16 cm, Pre-Curved, Kit - Model No. 8888135163; 16cm, Straight Extensions, IC Tray - Model No. 8888135164; 19.5cm, Straight Extensions, Kit - Model No. 8888135191; 19.5cm, Curved Extensions, Kit - Model No. 8888135192; 19.5cm, Pre-Curved, Kit - Model No. 8888135193; 19.5cm, Straight Extensions, IC Tray - Model No. 8888135194; 19.5cm, Curved Extensions, PASS Tray - Model No. 8888135198; 24cm, Straight Extensions, Kit - Model No. 8888135241; 24cm, Curved Extensions, Kit - Model No. 8888135242; 24cm, Pre-Curved, Kit - Model No. 8888135243
359,730 (23,003 US; 336,727 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model no. 8888135131, UDI-DI (GTIN) 20884521006208, Serial Numbers/Lots 1812900083 1813500125 1813500126 1813500127 1815000125 1815700093 1817700163 1818500134 1818500135 1818500136 1825400151 1825400152 1825400153 1826200138 1826200139…
Every code shown here, 1,997 characters
Model no. 8888135131, UDI-DI (GTIN) 20884521006208, Serial Numbers/Lots 1812900083 1813500125 1813500126 1813500127 1815000125 1815700093 1817700163 1818500134 1818500135 1818500136 1825400151 1825400152 1825400153 1826200138 1826200139 1830300127 1932300176 2001400063 2003900121 2005700199 2006500068 2010800195 2011300093 2019500161 2110900061 2110900084 2113300229 - Model no. 8888135132 UDI-DI (GTIN) 20884521006215 Serial numbers/Lots 1807900113 1809200136 1809200143 1810200110 1812200142 1819000116 1819000117 1819000118 1820500152 1826200094 1831100160 1835100093 1904200111 1906700209 1907700101 1911300213 1912600120 1912600121 1912600122 1913000102 1913000103 1920500250 1920500251 1921300045 1921300046 1921300047 1921900187 1921900188 1933000076 1934300146 2000700099 2002900105 2002900126 2002900127 2006500069 2007800043 2010800193 2010800194 2015100037 2016000060 2016700073 2201800062 - Model No. 8888135133 UDI/DI (GTIN) 20884521006253 Serial Numbers/Lots 1801000105 1803100140 1803700085 1806500174 1807300109 1807900112 1808200161 1812200141 1831100170 1831100171 1831100179 1834500174 1835100099 1835300240 1901400135 1902100148 1902800125 1926800454 1927500097 1927500117 1931500108 2019500182 2023400141 2035000068 2035000069 2104200114 2106900053 2106900056 2110900129 2201800060 - Model No. 8888135134 UDI/DI (GTIN) 20884521006284 Serial Number/Lot 2128000086 - Model no. 8888135161 UDI-DI (GTIN) 20884521006352 Serial Numbers/Lots 1800300109 1801000106 1801600120 1802300090 1803700086 1804500111 1806500176 1807300110 1808500123 1809200137 1810000110 1811500137 1812200145 1812900084 1820500155 1820500157 1820500159 1821300101 1823900099 1826200140 1826800111 1827600097 1827600098 1828900079 1831100166 1831100172 1834500175 1834500185 1835100094 1900700154 1900700155 1901400129 1901400130 1901400132 1902100143 1903500131 1904900105 1908400352 1908400353 1908800226 1908800227 1910200079 1913000191 1913000192 1914000254 1914000255 1914000256 1914000257 1923200090…
FDA’s list runs to 6,999 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution. US nationwide including Guam, USVI, and Puerto Rico; Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, Italy, Jamaica, Kenya, Malaysia, Malta, Mauritius, Mexico, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Uganda, United Arab Emirates, and United Kingdom.
The states and territories these words name
- Guam
- Puerto Rico
- US Virgin Islands
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 7, 2022.
- FDA classified it on Jan 12, 2023.
- FDA’s Enforcement Report published it on Jan 18, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Covidien LP, of Mansfield, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 6,999 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.