Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter recalled over labeling errors

Recall date

March 27, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Sustainability Solutions recalls Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm,…

Recall number

Z-2113-2020

FDA classification

Class II

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

US: AZ, CA, FL, GA, ID, IL, IN, KS, MA, MO, PA, TN, TX, VA, WA, WV OUS: None

Why it was recalled

A subset of temporary intracardiac ultrasound catheters are labeled with the incorrect expiration date. They are mislabeled as having a shelf life of two years, while the actual shelf life is one year. The earliest affected product will expire in May 2020. Use of mislabeled devices may lead to hazards sterility breach, component breakdown or delay in treatment.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067