Device product
Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C - Product Usage: To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.
Z-2881-2020
Product summary
- Event
- Event 86146
- Status
- Terminated
- Classification
- Class II
- Quantity
- 111 units
- Official record key
device-enforcement:Z-2881-2020
Official wording
Reason: Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.
Code information: Lots R7504-30C: 70621Y and 81008X R7504-35BC: 70415V and 71220V R7504-35C: 81008W R7644-32.5BC: 71228S RC7221-25BC: 70502Y and 70621W RC7504-17.5C: 80411A and 80802W
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.
Derived failure modes
-
Unknown
Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.