Cook Inc. recalls Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

Recall date

April 9, 2019

Source

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

Recall number

Z-1723-2019

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA

Why it was recalled

Affected products may have been manufactured with the catheter distal end hole too small

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

What was recalled

Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284