| Class 2 Device Recall STERLING Zero Nitrile PowderFree Exam Gloves | |
Date Initiated by Firm | September 27, 2021 |
Create Date | December 01, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0317-2022 |
Recall Event ID |
88846 |
510(K)Number | K182851 |
Product Classification |
Patient examination glove, specialty - Product Code LZC
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Product | HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL |
Code Information |
All lots of the following sizes:
a. XS, REF 47459, UDI (01)20680651474593
b. S, REF 47460, UDI (01)20680651474609
c. M, REF 47461, UDI (01)20680651474616
d. L, REF 47462, UDI (01)20680651474623
e. XL, REF 47463, UDI (01)20680651474630 |
Recalling Firm/ Manufacturer |
O&M HALYARD INC 1 Edison Dr Alpharetta GA 30004-3894
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For Additional Information Contact | Pam Strickland 470-602-2900 |
Manufacturer Reason for Recall | All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing. |
FDA Determined Cause 2 | Component design/selection |
Action | O&M Halyard Inc has issued a voluntary recall of the Sterling Zero Nitrile Powder-free Exam Glove on 10/08/2021 by email or Fed Ex. The letter requested that the consignee segregate and destroy all affected product. Distributors were directed to notify their customers.
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Quantity in Commerce | 2,928 cases (5,856,000 gloves) |
Distribution | Worldwide distribution - US Nationwide and the countries of EU/Canada. |
Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = LZC
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