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MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 881379...

FDA Device Recall #Z-1955-2019 — Class II — April 29, 2019

Recall Summary

Recall Number Z-1955-2019
Classification Class II — Moderate risk
Date Initiated April 29, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm COVIDIEN LLC
Location Mansfield, MA
Product Type Devices
Quantity 2,223,067

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.

Distribution Pattern

Nationwide domestic distribution. Foreign distribution to Canada, Australia, New Zealand, Latin America, and Hong Kong.

Lot / Code Information

All lots

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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