MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery.
FDA Recall Z-0051-2017 · Posted 2016-10-07
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Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2016-09-08
Date Terminated2017-06-07
Product Quantity200 units
Reason for Recall
The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath
Firm Action
An Urgent - Product Recall Notice was sent to consignees identifying the affected device and the reason for the recall. Customers were asked to return all affected devices. The firm will send replacement devices upon receipt of the returned affected product and once assembly of a cleared lot that does not contain recalled devices has been completed. If there are questions regarding the letter or recall action, customers can contact [email protected].
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- US, to the states of TN and MS; and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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