Recall Z-3281-2018— Stryker Neurovascular

Name: FDA recall Z-3281-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-02

Class II · Terminated

Class II FDA medical device recall by Stryker Neurovascular, initiated 2018-05-02. It names one FDA 510(k) clearance: K152876. 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, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.. Reason: The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded..

Recalling firm: Stryker Neurovascular
Classification: Class II
Status: Terminated
Initiated: 2018-05-02
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K152876 — LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CMTni Manufacturing, Inc.·cleared 2016-01-08

K-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

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, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.

Reason for recall

The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded.

Data sourced from openFDA. This site is unofficial and independent of the FDA.