Recirculator 8.0s Disposable Lavage Kit recall
Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the…
Why was Recirculator 8.0s Disposable Lavage Kit recalled?
The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 08719992086016 Lot Numbers: 20021361 20202106 20202106 20018480 19854186 20019438 20018480 19854186 19854185 20202106 20019438 19854184 20202106 20018480 20202106 20018480 18687686
- Product
- Recirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. Hyperthermic Perfusion System intended to raise the…
- Recalling firm
- Eight Medical International BV
- Quantity
- 22
- Distribution
- US Nationwide, Colombia, and Dubai.
- Recall date
- August 4, 2021
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)