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Argon Medical Devices, Inc Recall 88520

Description: Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.

Argon Medical Devices, Inc Recall 88520 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2501-2021
Event ID88520
Event DescriptionScorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
Product TypeDevices
DistributionU.S. Nationwide distribution in the state of WA. O.U.S.: N/A
Quantity20 units
Recall ReasonAs a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Device Classification20210929
Device Code InfoItem Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609
Center Classification Date20210921
Recall Initiation Date20210708
Recalling FirmArgon Medical Devices, Inc
Initial Notification Letter
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