Pack, Hot Or Cold, Reusable
Cardinal Health's record for this product code
Recent MDR events
15 adverse event reports on file
- CARDINAL HEALTH INSULATED GEL PACKJun 22, 2023Injury17181232
- NOVAPLUS INSTANT HOT PACKSep 5, 2018InjuryMW5079635
- INSTANT HOT PACKJul 2, 2018Malfunction7654275
- REUSABLE GEL PACK, M, 4.5X10.5INMar 14, 2017Injury1423537-2017-00076
- *Jun 4, 2013Malfunction3148640
- REUS GEL PK SM 4.5X7Sep 26, 2011Malfunction1423537-2011-00034
- REUS COLD PK SM 5.5X7May 18, 2010Other1423507-2010-00028
- REUS INSUL GEL PK JUMBOMar 5, 2009Other1423507-2009-00029
- LOWER EXTREMITY (LXELI)145Mar 27, 2006Other1423507-2006-00034
- CAROLON 6X10 GEL 24/CSDec 6, 2005Other1423507-2005-00142
Recalls
8 recall events for this product code
- Open, ClassifiedNov 7, 2022
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 .
View FDA record ↗ - Open, ClassifiedNov 7, 2022
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 .
View FDA record ↗ - Open, ClassifiedNov 7, 2022
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 .
View FDA record ↗ - Open, ClassifiedNov 7, 2022
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 .
View FDA record ↗ - Open, ClassifiedNov 7, 2022
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 .
View FDA record ↗ - Open, ClassifiedNov 7, 2022
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 .
View FDA record ↗ - Open, ClassifiedNov 7, 2022
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 .
View FDA record ↗ - Open, ClassifiedNov 7, 2022
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 .
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Cardinal Health under this product code.