Severity
Moderate
MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 8817149007 8817232018 8817232019 8817277007 8817277011 8817277021 8817277027 8830414001 8830414002 8830415001 8830415003 8830416001 8830416003 8830416021 8830416023 8831173010 8831173011 8831173012 8831661001 8
Reported: July 17, 2019 Initiated: April 29, 2019 #Z-1955-2019 2,223,067 units
COVIDIEN LLC issued this FDA Devices recall on July 17, 2019. Classified as Moderate severity (Class II). Approximately 2,223,067 units are affected. The recall was issued because: The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher t…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1955-2019) was formally reported on July 17, 2019, with the manufacturer initiating the action on April 29, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. COVIDIEN LLC is listed as the recalling firm, operating out of Mansfield, MA. Federal records indicate 2,223,067 units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen. Distribution data in the federal record shows the product reached: Nationwide domestic distribution. Foreign distribution to Canada, Australia, New Zealand, Latin America, and Hong Kong.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 7 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
2,223,067
Related Recalls
6
6 from same agency
Product Description
MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 8817149007 8817232018 8817232019 8817277007 8817277011 8817277021 8817277027 8830414001 8830414002 8830415001 8830415003 8830416001 8830416003 8830416021 8830416023 8831173010 8831173011 8831173012 8831661001 8831662001 8831663001 8831663002 8831663021 8831663022 8832539001 8832539002 8832539003 8832539006 8832539007 8888115132 8888115133 8888115162 8888115163 8888115192 8888115193 8888115242 8888115243 8888135131 8888135132 8888135133 8888135134 8888135135 8888135136 8888135137 8888135138 8888135139 8888135140 8888135141 8888135142 8888135161 8888135162 8888135163 8888135164 8888135165 8888135166 8888135167 8888135168 8888135191 8888135192 8888135193 8888135194 8888135195 8888135196 8888135197 8888135198 8888135241 8888135242 8888135243 8888135244 8888135245 8888135246 8888135247 8888135248 8888340629 8888340637 8888345504 8888345512 8888345520 8888345538 8888345603 8888345611 8888345629 8888345637 8888101001HP 8888101002HP 8888101003HP 8888101004HP 8888102003HP 8888102004HP 8888103001HP 8888103002HP 8888103003HP 8888103004HP 8888104003HP 8888104004HP 8888340629HP 8888340637HP 8888345504HP 8888345512HP 8888345520HP 8888345538HP 8888345603HP 8888345611HP 8888345629HP 8888345637HP
Reason for Recall
The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
Details
- Recalling Firm
- COVIDIEN LLC
- Units Affected
- 2,223,067
- Distribution
- Nationwide domestic distribution. Foreign distribution to Canada, Australia, New Zealand, Latin America, and Hong Kong.
- Location
- Mansfield, MA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1955-2019 |
| Date reported | July 17, 2019 |
| Date initiated | April 29, 2019 |
| Recalling firm | COVIDIEN LLC |
| Units affected | 2,223,067 |
| Distribution | Nationwide domestic distribution. Foreign distribution to Canada, Australia, New Zealand, Latin America, and Hong Kong. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 8817149007 8817232018 8817232019 8817277007 8817277011 8817277021 8817277027 8830414001 8830414002 8830415001 8830415003 8830416001 8830416003 8830416021 8830416023 8831173010 8831173011 8831173012 8831661001 8831662001 8831663001 8831663002 8831663021 8831663022 8832539001 8832539002 8832539003 8832539006 8832539007 8888115132 8888115133 8888115162 8888115163 8888115192 8888115193 8888115242 8888115243 8888135131 8888135132 8888135133 8888135134 8888135135 8888135136 8888135137 8888135138 8888135139 8888135140 8888135141 8888135142 8888135161 8888135162 8888135163 8888135164 8888135165 8888135166 8888135167 8888135168 8888135191 8888135192 8888135193 8888135194 8888135195 8888135196 8888135197 8888135198 8888135241 8888135242 8888135243 8888135244 8888135245 8888135246 8888135247 8888135248 8888340629 8888340637 8888345504 8888345512 8888345520 8888345538 8888345603 8888345611 8888345629 8888345637 8888101001HP 8888101002HP 8888101003HP 8888101004HP 8888102003HP 8888102004HP 8888103001HP 8888103002HP 8888103003HP 8888103004HP 8888104003HP 8888104004HP 8888340629HP 8888340637HP 8888345504HP 8888345512HP 8888345520HP 8888345538HP 8888345603HP 8888345611HP 8888345629HP 8888345637HP. Recalled by COVIDIEN LLC. Units affected: 2,223,067.
Why was this product recalled? ▼
The priming volume values printed on the MAHURKA and Argyle acute catheters and Instructions for Use (IFU) are higher than the volumes required to fill each lumen.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 17, 2019. Severity: Moderate. Recall number: Z-1955-2019.
Where was the recalled product distributed? ▼
Distribution: Nationwide domestic distribution. Foreign distribution to Canada, Australia, New Zealand, Latin America, and Hong Kong..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1955-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).