SOLOPATH Re-Collapsible Access System recall
SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
Why was SOLOPATH Re-Collapsible Access System recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Codes:VG26 VH21 VL20 VL29 VN29 WP05 VG02 VG07 VG13 VK29 VL18 WA25 WD02 WE25 WF09 WK01 WK09 WP05 XA09 VG06 VH27 VK04 XA09 VH27 VK07 VL28 WL14 XA30 VF31 VG16 VH21 WE25 WH23 WK01 VG09 VG14 VL14 VP18 WN07 XA09
- Product
- SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
- Recalling firm
- Terumo Medical Corporation
- Quantity
- 1431
- Distribution
- The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.
- Recall date
- June 5, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)