Medical device recalls Moderate risk

Edwards Lifesciences, LLC recalls Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181

Recall date
March 27, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2007-2020
FDA classification
Class II
Brand / firm
Edwards Lifesciences, LLC
Sold / distributed
US - AZ, CA, FL, GA, IA, IL, IN, KY, MA, MD, MO, SC, TN, TX and VA.

Why it was recalled

Sterile catheter kit packaging compromised.

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

What was recalled

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

Get recall alerts

Free email alert whenever Edwards Lifesciences, LLC has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Edwards Lifesciences, LLC