Recall Z-2007-2020— Edwards Lifesciences, LLC

Name: FDA recall Z-2007-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-27

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2020-03-27, terminated 2021-04-27. It names one FDA 510(k) clearance: K172423. Product: Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181. Reason: Sterile catheter kit packaging compromised..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-03-27
Terminated: 2021-04-27
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)Edwards Lifescience, LLC·cleared 2018-02-20

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

Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

Reason for recall

Sterile catheter kit packaging compromised.

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