Stryker Corporation recalls STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Mode…

Recall date

November 17, 2017

Source

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

Recall number

Z-0836-2018

FDA classification

Class II

Brand / firm

Stryker Corporation

Sold / distributed

Distributed domestically to . Distributed internationally to Australia and Mexico.

Why it was recalled

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

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

What was recalled

STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);