Z-0758-2017 Class II Terminated
FDA device recall Z-0758-2017 was initiated by Halyard Health on November 10, 2016 and is designated Class II. Reason for recall: Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing. The recall status is terminated (terminated May 4, 2017). Affected quantity: 59 cases.
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2016
- Initiation Date
- November 10, 2016
- Termination Date
- May 4, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 cases
Product Description
Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
Reason for Recall
Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
Distribution Pattern
CA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT.
Code Information
Product Code: 53130 01 (105313001), Lot numbers: SM52741 and SM52721.