CooperSurgical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1301-2015)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2015.
Data Source: FDA.
Product Description:
NovaPlus Brand Warm Gel Infant Heel Gel Warmer, Item # V6391 NovaPlus Brand Liquid Heal Warmer. Item #V6393 Single Use and Disposable To provide gentle heat to increase blood flow and enhance infant blood sample collection
Product Classification:
Class II
Date Initiated: January 26, 2015
Date Posted: March 25, 2015
Recall Number: Z-1301-2015
Event ID: 70286
Reason for Recall:
Products without expiration date have the remote potential for minor burn
Status: Terminated
Product Quantity: 4938266 units
Code Information:
Products without an expiration date and lot number
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.
Voluntary or Mandated:
Voluntary: Firm initiated