AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm recall
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland…
Why was AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm recalled?
The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.
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 No. 20156091 ;UPN: GEN-10800-80-S2 UDI (01)07613327298253 (17)201130 (10) 20156091.
- Product
- AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland…
- Recalling firm
- Stryker Neurovascular
- Quantity
- 15 units
- Distribution
- Only U.S. Consignees: CO,NJ,NY, OH,PA, and WV.
- Recall date
- October 10, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)