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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2577-2021 |
| Event ID | 88611 |
| Event 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. |
| Product Type | Devices |
| Distribution | US nationwide distribution. |
| Quantity | 3118 units |
| Recall Reason | There is a potential for distal end of catheters to fracture and become detached. |
| Device Classification | 20211006 |
| Device Code Info | Affected 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 Date | 20210929 |
| Recall Initiation Date | 20210813 |
| Recalling Firm | IMPERATIVE CARE INC |
| Initial Notification | Letter |
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