FDA-Device2021-10-06Class I
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
Hazard
There is a potential for distal end of catheters to fracture and become detached.
Sold states
US nationwide distribution.
Affected count
3118 units
Manufactured in
1359 Dell Ave, N/A, Campbell, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2577-2021Don't want to check this manually?
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