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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 26, 2017
Create Date January 26, 2018
Recall Status1 Terminated 3 on April 06, 2021
Recall Number Z-0417-2018
Recall Event ID 78058
Product Classification Infant Positioner, Rx, Use In Highly Monitored Setting - Product Code OUW
Product 9x15" Medium Utility Positioner with Cover
Code Information Recorder Code 1400239
Recalling Firm/
Molnlycke Health Care, Inc
5550 Peachtree Pkwy Ste 500
Norcross GA 30092-2555
For Additional Information Contact
Manufacturer Reason
for Recall
Products may not meet specifications due to possible presence of metal shavings.
FDA Determined
Cause 2
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 204 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.