Recall Z-1375-2019— Terumo Medical Corporation
Class I · Terminated
Class I FDA medical device recall by Terumo Medical Corporation, initiated 2019-04-26, terminated 2020-09-22. It names one FDA 510(k) clearance: K152498. Product: SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435. Reason: There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath..
- Recalling firm
- Terumo Medical Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2019-04-26
- Terminated
- 2020-09-22
- Firm location
- Elkton, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
Reason for recall
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Data sourced from openFDA. This site is unofficial and independent of the FDA.