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Z-0416-2018 Class II Terminated

Recalled by Molnlycke Health Care, Inc — Norcross, GA

FDA device recall Z-0416-2018 was initiated by Molnlycke Health Care, Inc on July 26, 2017 and is designated Class II. Reason for recall: Products may not meet specifications due to possible presence of metal shavings. The recall status is terminated (terminated April 6, 2021). Affected quantity: 960 units total.

Recall Details

Product Type: Devices
Report Date: February 7, 2018
Initiation Date: July 26, 2017
Termination Date: April 6, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 960 units total

Product Description

7x10" Small Utility Positioner with Cover

Reason for Recall

Products may not meet specifications due to possible presence of metal shavings.

Distribution Pattern

Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.

Code Information

Recorder Code 1400227