Class 2 Device Recall NovaPlus

• Date Initiated by Firm: January 26, 2015
• Date Posted: March 19, 2015
• Recall Status: Terminated on June 14, 2016
• Recall Number: Z-1301-2015
• Recall Event ID: 70286
• 510(K)Number: K912715
• Product Classification: Pack, hot or cold, disposable - Product Code IMD
• Product: 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
• Code Information: Products without an expiration date and lot number
• Recalling Firm/ Manufacturer: CooperSurgical, Inc.; 75 Corporate Dr; Trumbull CT 06611-1350
• For Additional Information Contact: Customer Service; 203-601-9818
• Manufacturer Reason for Recall: Products without expiration date have the remote potential for minor burn
• FDA Determined Cause: Package design/selection
• Action: CooperSurgical issued Recall Notification letter on January 26, 2015, via Fedex confirmed receipt delivery, to all affected customers. Customers were requested to review inventory and return/destroy product that does not have a expiration and lot number. A fax back form to be returned. Customers with questions should call 203.601.5200. CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement.
• Quantity in Commerce: 4938266 units
• Distribution: Worldwide Distribution - USA (nationwide) and Internationally to AUSTRALIA, BAHRAIN, BERMUDA, CANADA, FRANCE, LATVIA, LIBYA, MEXICO, NEW ZEALAND, QATAR, SAUDI ARABIA, SINGAPORE, and UNITED KINGDOM.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IMD