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Green Sprouts
O2cool, LLC · Model 379300-916-00 · UDI-DI 00715418094045
10
510(k) clearances
323
Adverse events (1 deaths)
12
Recalls
472
Facilities
Description
Cool Calm Press-Assorted-Adult use only
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-25 | DJO, LLC | The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2022-09-28 | Cardinal Health 200, LLC | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates . |
| 2021-12-15 | MEDLINE INDUSTRIES, LP - Northfield | The product contains natural rubber latex but the label states that it does not. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.