Novaplus
NovaPlus Infant Heel Warmer
2manufacturers in China registered for this device type
1catalogue number
3recalls on this code
Who Else Makes It
All of them in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Intco Medical Products Co., Ltd. | Zhenjiang New District | Jiangsu | Manufacturer | 18 |
| Danyang Rapid Aid Hot and Cold Therapy Products Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | MPO |
| Device type | Infant Heel Warmer (Chemical Heat Pack) |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5710 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2023-02-27 |
| Record revised | 2026-01-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Storage | Storage environment temperature up to 40 °C |
| Packaging | Box of 25, case of 4 |
| Sizes | Height 4 in; width 4 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V11460-010 | Height 4 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Medline | Medline Industries, Inc. | 3 |
| Future Generation Medical | Global International L. L. C. | 2 |
| ASP Medical | ASP Global, LLC | 2 |
| Argyle | Cardinal Health | 2 |
| MediChoice | Owens & Minor Distribution, Inc. | 2 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| Halyard | Owens & Minor Distribution, Inc. | 2 |
| PremierPro | Prestige Ameritech | 1 |
| GCB Medical Supply | GCB Medical LLC | 1 |
| Infant Heel Snuggler | International Biomedical, Ltd. | 1 |
| Sammons Preston | Performance Health Supply, Inc. | 1 |
Showing 12 of 20. All products under Infant Heel Warmer (Chemical Heat Pack)
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-06-16 | Class II | Process control | Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape. | 44,500 units | |
| 2021-06-09 | Class II | Package design/selection | A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential h | 926,425 units | 2023-11-01 |
| 2021-06-09 | Class II | Package design/selection | A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential h | 2,911,064 units | 2023-11-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.