Recall Z-0836-2018— Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Corporation, initiated 2017-11-17, terminated 2024-01-29. It names one FDA 510(k) clearance: K042454. 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: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates..
- Recalling firm
- Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-17
- Terminated
- 2024-01-29
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.