T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. recalls FlipCutter III Drill

Recall date

January 20, 2020

Source

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

Recall number

Z-1542-2020

FDA classification

Class II

Brand / firm

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.

Sold / distributed

Product distributed throughout the United States, Austria, Australia, Bermuda, Switzerland, China, Germany, Denmark, France, Great Britain, Italy, Netherlands, Poland, Sweden and Taiwan.

Why it was recalled

There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.

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

What was recalled

FlipCutter III Drill