FDA-Device2018-03-14Class II
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);
Stryker Corporation
Hazard
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Sold states
Distributed domestically to . Distributed internationally to Australia and Mexico.
Affected count
60,753 units total
Manufactured in
5900 Optical Ct, N/A, San Jose, CA, United States
Products
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);
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0836-2018Don't want to check this manually?
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