Z-2881-2020 Class II Terminated
FDA device recall Z-2881-2020 was initiated by Klarity Medical Products LLC on Jul 31, 2020 and is designated Class II. Reason for recall: Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times. The recall status is terminated (terminated Oct 19, 2020). Affected quantity: 111 units.
Recall details
- Product Type
- Devices
- Report Date
- Sep 2, 2020
- Initiation Date
- Jul 31, 2020
- Termination Date
- Oct 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 111 units
Product description
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.
Reason for recall
Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.
Distribution pattern
Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2881-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026