Recall record at a glance
| Official record | Z-2881-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Klarity Medical Products LLC |
| Report date | Sep 2, 2020 |
| Recall initiation date | Jul 31, 2020 |
| Quantity | 111 units |
| Location | Heath, OH, United States |
Official 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.
Why the product was recalled
Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.
Distribution information
Worldwide distribution - US Nationwide distribution including in the states of CA, FL, MA, NY, PA and the country of UK.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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