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

Recalled March 14, 2018 · FDA recall Z-0836-2018 · Stryker

Hazard

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

Units

60,753 units total

Sold at

Distributed domestically to . Distributed internationally to Australia and Mexico.

Description

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

Product

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);

Manufacturer(s)

Stryker Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →