Z-1300-2015 Class II Terminated
FDA device recall Z-1300-2015 was initiated by CooperSurgical, Inc. on Jan 26, 2015 and is designated Class II. Reason for recall: Products without expiration date have the remote potential for minor burn The recall status is terminated (terminated Jun 14, 2016). Affected quantity: 18696754 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 25, 2015
- Initiation Date
- Jan 26, 2015
- Termination Date
- Jun 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18696754 units
Product Description
MediChoice WarmGel Infant Heel Warmer, Item # 1643069911 MediChoice Liquid Infant Heel Warmer, Item # 1643069912 Single Use and Disposable. Distributed by: Owens & Minor. To provide gentle heat to increase blood flow and enhance infant blood sample collection
Reason for Recall
Products without expiration date have the remote potential for minor burn
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.
Code Information
Products without an expiration date and lot number
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1300-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026