Klarity Vacuum Bags Recalled for Inadequate Vacuum Retention During Radiation Therapy
Klarity Medical Products LLC is recalling 111 vacuum bags used for patient positioning during radiation therapy because they may not hold a vacuum adequately for the required treatment time.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm to patients during a medical procedure (radiation therapy) due to inadequate device performance, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Klarity Medical Products LLC is recalling 111 units of Klarity Vacuum Bags, Item Nos. R7504-30C, R7504-35BC, R7504-35C, R7644-32.5BC, RC7221-25BC, and RC7504-17.5C. These medical devices are used by trained medical professionals to provide stable support and positioning for patients undergoing external beam radiation therapy in clinic or hospital settings.
The recall was initiated because the vacuum bags potentially may not hold their vacuum adequately for the needed patient treatment times. This defect could compromise the stability of the patient's position during radiation therapy.
The affected units were distributed worldwide, including nationwide in the United States and in the United Kingdom. Specific distribution in the US included California, Florida, Massachusetts, New York, and Pennsylvania. The recall covers specific lot numbers for each item number, including 70621Y and 81008X for R7504-30C, and 70415V and 71220V for R7504-35BC. Healthcare facilities and consumers should check their inventory against the listed item numbers and lot codes to identify affected units.
The recalled product
- 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…
- Manufacturer
- Klarity Medical Products LLC
- Affected units
- 111
Distribution
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