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U.S. Department of Health and Human Services

Class 2 Device Recall STERLING Zero Nitrile PowderFree Exam Gloves

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 Class 2 Device Recall STERLING Zero Nitrile PowderFree Exam Glovessee related information
Date Initiated by FirmSeptember 27, 2021
Create DateDecember 01, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0317-2022
Recall Event ID 88846
510(K)NumberK182851 
Product Classification Patient examination glove, specialty - Product Code LZC
ProductHALYARD 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
FEI Number 3014421917
Recalling Firm/
Manufacturer		 O&M HALYARD INC
1 Edison Dr
Alpharetta GA 30004-3894
For Additional Information ContactPam 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
ActionO&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.
Quantity in Commerce2,928 cases (5,856,000 gloves)
DistributionWorldwide distribution - US Nationwide and the countries of EU/Canada.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LZC
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