510(k) K964523 ยท MPO Infant Heel Warmer (Chemical Heat Pack)
RECOVER INFANT HEEL WARMER (5100)
| Applicant | Florida Medical Industries, Inc., Tarpon Springs FL, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Nov 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964523
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2021 | Cardinal Health 200, LLC Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product
SKU MH00002T
The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside the Terminated |
MPO | None listed |
| Jun 9, 2021 | Cardinal Health 200, LLC Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product
SKU MH00002N
The infant heel warmer is activated at the point of care by squeezing the pouch. This mixes the substrates inside t Terminated |
MPO | None listed |
| Aug 21, 2015 | Covidien LLC Covidien Argyle Infant Heel Warmers (no tab)
Item Code: MH00002N
Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling Terminated |
MPO | None listed |
| Aug 21, 2015 | Covidien LLC Covidien Argyle Infant Heel Warmers (with tab)
Item Code: MH00002T
Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling. Terminated |
MPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.