Device 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);
Z-0836-2018
Product summary
- Event
- Event 78668
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60,753 units total
- Official record key
device-enforcement:Z-0836-2018
Official wording
Reason: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Code information: a. Model 0250070600, UDI 07613327061499, Lot No. 17284FG2, 17291FG2, 17300FG2; b. Model 0250070620, UDI 07613327061659, Lot No. 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, 17299FG2;
Distribution pattern: Distributed domestically to . Distributed internationally to Australia and Mexico.
Derived failure modes
-
Microbial contamination
bioburden testing of certain lots were found