FDA recall Z-1955-2019

Product

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 888813519

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

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

Key facts

Status

Terminated

Initiation date

2019-04-29

Report date

2019-07-17

Termination date

2024-01-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1955-2019