Infant Heel Warmer and Infant Gel Warmer recall
Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL…
Why was Infant Heel Warmer and Infant Gel Warmer recalled?
Product marketed without a 510(k)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lot numbers
- Product
- Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL…
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 6,344,700
- Distribution
- Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM.
- Recall date
- July 29, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)