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Open, Classified

HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL

FDA Recall Z-0317-2022 · Posted None

Recalling FirmO&M HALYARD INC
Recall StatusOpen, Classified
Product CodeLZC
Date Initiated2021-09-27
Product Quantity2,928 cases (5,856,000 gloves)

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of EU/Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182851SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsO&M Halyard, Inc. · 2019-06-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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