FDA Medical Device Recalls (openFDA)
Klarity Medical Products LLC: 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.
- Recall number
- Z-2881-2020
- Recalling firm
- Klarity Medical Products LLC
- 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.
- Status
- Terminated
- Initiated
- 2020-07-31
- Posted
- not on file
- Terminated
- 2020-10-19
- Reason
- Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.
- Root cause
- Component design/selection
- Action
- On July 31, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers, informing them that vacuum bags may experience product failure wherein the bags fail to maintain an adequate vacuum over a required period of time. The loss of vacuum can lead to treatment inaccuracy due to shift of patient location. Customers were instructed to: 1. Inspect current inventory to locate any affected product. 2. Remove product from service. 3. Destroy and dispose of product (the firm recommended cutting up and disposing with normal trash). Klarity will replace affected bags or reimburse your cost, as you choose. 4. Complete the customer response form to confirm receipt of notice and actions taken. If any questions, please contact: Sherry Angus, Klarity Quality Manager. Ph. 740-788-8107 ext.119, sherry@klaritymedical.com
- Quantity
- 111 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K132124"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3001236129
- Firm city
- Heath
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28