Class 2 Device Recall

• Date Initiated by Firm: July 26, 2017
• Create Date: January 26, 2018
• Recall Status: Terminated on April 06, 2021
• Recall Number: Z-0416-2018
• Recall Event ID: 78058
• Product Classification: Infant Positioner, Rx, Use In Highly Monitored Setting - Product Code OUW
• Product: 7x10" Small Utility Positioner with Cover
• Code Information: Recorder Code 1400227
• Recalling Firm/ Manufacturer: Molnlycke Health Care, Inc; 5550 Peachtree Pkwy Ste 500; Norcross GA 30092-2555
• For Additional Information Contact: 470-250-7952
• Manufacturer Reason for Recall: Products may not meet specifications due to possible presence of metal shavings.
• FDA Determined Cause: Under Investigation by firm
• Action: Customers were notified by letter via overnight mail on approximately 07/26/2017. Instructions include identify and quarantine affected product in inventory, contact Molnlycke to arrange return of affected product, and complete and return the Acknowledgement Form.
• Quantity in Commerce: 960 units total
• Distribution: Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
• 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.