Recall Z-2235-2021— Cordis Corporation

Name: FDA recall Z-2235-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-19

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2021-07-19, terminated 2023-02-16. It names one FDA 510(k) clearance: K133843. Product: Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X. Reason: The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon..

Recalling firm: Cordis Corporation
Classification: Class II
Status: Terminated
Initiated: 2021-07-19
Terminated: 2023-02-16
Firm location: Miami Lakes, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K133843 — SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETERCordis Corporation·cleared 2014-06-27

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

Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

Reason for recall

The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.

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