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);
Reported: March 14, 2018 Initiated: November 17, 2017 #Z-0836-2018
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.
Details
- Recalling Firm
- Stryker Corporation
- Units Affected
- 60,753 units total
- Distribution
- Distributed domestically to . Distributed internationally to Australia and Mexico.
- Location
- San Jose, CA
Frequently Asked Questions
What product was recalled? ▼
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);. Recalled by Stryker Corporation. Units affected: 60,753 units total.
Why was this product recalled? ▼
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 14, 2018. Severity: Moderate. Recall number: Z-0836-2018.
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