Recall Z-2281-2021— Edwards Lifesciences, LLC

Name: FDA recall Z-2281-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-09

Class II · Terminated

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2021-07-09, terminated 2024-01-29. It names one FDA 510(k) clearance: K053609. Product: Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US. Reason: There is a potential for internal leaks within catheters..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-07-09
Terminated: 2024-01-29
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K053609 — PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOREdwards Lifesciences, LLC·cleared 2006-02-28

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

Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US

Reason for recall

There is a potential for internal leaks within catheters.

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