Z-2147-2015 Class II Terminated
FDA device recall Z-2147-2015 was initiated by CooperSurgical, Inc. on Jul 6, 2015 and is designated Class II. Reason for recall: Product marketed without a 510(k) The recall status is terminated (terminated Jun 14, 2016). Affected quantity: 6,344,700.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 29, 2015
- Initiation Date
- Jul 6, 2015
- Termination Date
- Jun 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,344,700
Product Description
Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX
Reason for Recall
Product marketed without a 510(k)
Distribution Pattern
Worldwide Distribution - Nationwide Distribution and to the countries of : AUSTRALIA, BERMUDA, ECUADOR , FRANCE, NEW ZEALAND, SAUDI ARABIA and UNITED KINGDOM.
Code Information
All lot numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2147-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026