FDA recall Z-0836-2018

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);

Reason for recall

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

Distribution

Distributed domestically to . Distributed internationally to Australia and Mexico.

Key facts

Status

Terminated

Initiation date

2017-11-17

Report date

2018-03-14

Termination date

2024-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0836-2018