Device product
Comprehensive RS Cleat CAP, Item No. 110300
Z-0525-2020
Product summary
- Event
- Event 83783
- Status
- Terminated
- Classification
- Class II
- Quantity
- 219988 units (total)
- Official record key
device-enforcement:Z-0525-2020
Official wording
Reason: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Code information: 126590 126600 502890 502900 502910 012080 941080
Distribution pattern: US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela.
Derived failure modes
-
Unknown
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.