Recall Z-0317-2022 ยท LZC Medical Glove, Specialty
O&M HALYARD INC
HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
| Date | Sep 27, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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. |
| Quantity | 2,928 cases (5,856,000 gloves) |
| Distribution | Worldwide distribution - US Nationwide and the countries of EU/Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182851 | SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs O&M Halyard, Inc., Jun 26, 2019 |