Class 2 Device Recall STERLING NITRILE

• Date Initiated by Firm: November 10, 2016
• Date Posted: December 14, 2016
• Recall Status: Terminated on May 04, 2017
• Recall Number: Z-0758-2017
• Recall Event ID: 75663
• 510(K)Number: K081027
• Product Classification: Polymer patient examination glove - Product Code LZA
• Product: Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
• Code Information: Product Code: 53130 01 (105313001), Lot numbers: SM52741 and SM52721.
• FEI Number: 3011157493
• Recalling Firm/ Manufacturer: Halyard Health; 1400 Holcomb Bridge Rd; Roswell GA 30076-2190
• For Additional Information Contact: Thomas Kozma, PhD; 470-445-5681
• Manufacturer Reason for Recall: Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
• FDA Determined Cause: Under Investigation by firm
• Action: Consignees were notified by letter via Fed Ex on/about 11/10/2016.
• Quantity in Commerce: 59 cases
• Distribution: CA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT.
• 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 = LZA