Product Safety Recalls

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IMPERATIVE CARE INC Recall 88611

Description: Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.

IMPERATIVE CARE INC Recall 88611 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2577-2021
Event ID88611
Event DescriptionImperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
Product TypeDevices
DistributionUS nationwide distribution.
Quantity3118 units
Recall ReasonThere is a potential for distal end of catheters to fracture and become detached.
Device Classification20211006
Device Code InfoAffected Lots: V2014902, F2026201, F2026802, F2028801, F2028901, F2029501, F2029701, F2030801, F2031101, F2035301, F2032502, F2100802, F2101301, F2104102, F2108101, F2108801, F2109601, F2109701, F2111101, F2110601, F2112301, F2113004, F2112001
Center Classification Date20210929
Recall Initiation Date20210813
Recalling FirmIMPERATIVE CARE INC
Initial Notification Letter
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