Edwards Lifesciences, LLC: Medical Device Recall in 2020 - (Recall #: Z-2007-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 27, 2020

Date Posted: May 20, 2020

Recall Number: Z-2007-2020

Event ID: 85483

Reason for Recall:

Sterile catheter kit packaging compromised.

Status: Terminated

Product Quantity: 597 units

Code Information:

Model: XA3816SFKT LOT CODES: 62563142, 62157774, 62132722, 62749306, 62625932

Distribution Pattern:

US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.

Voluntary or Mandated:

Voluntary: Firm initiated