Z-2881-2020Class II

Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C -

Name: Z-2881-2020 Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC,R7504-35C, R7644-32.5BC, RC7221-25BC, RC7504-17.5C -
Creator: Klarity Medical Products LLC
Published: 2020-07-31
License: https://open.fda.gov/license/

Klarity Medical Products LLC / initiated 2020-07-31 / Terminated / root cause: design

FDA source

Klarity Medical Products LLC began a recall of 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... on 2020-07-31. FDA classified it as Class II and gives the reason as "Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2881-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-31
Posted: 2020-08-24
Terminated: 2020-10-19
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.
Root cause tag: design
FDA 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, [email protected]
Quantity in commerce: 111 units
Distribution: Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2881-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2881-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-24

Product code IYE

K132124Class IIKlarity Vacuum Bag, Klarity Mold CushionKlarity Medical Products, LLC / cleared 2013-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)