Reported Jul 29, 2015 · Terminated
Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows :…
CooperSurgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 75 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows
4 of 4 products
| Model / number | Product as published |
|---|---|
20418 | CooperSurgical WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100 |
24401 | LIQUID INFANT HEEL WARMER - PRISM BOX OF 100 |
24647 | and Fisher Brand. FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100 |
24646 | FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX |
- Lot codes and dates
- All lot numbers
- Amount recalled
- 6,344,700
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Product marketed without a 510(k)
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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