Device product
Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
Z-0758-2017
Product summary
- Firm
- Halyard Health
- Event
- Event 75663
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59 cases
- Official record key
device-enforcement:Z-0758-2017
Official wording
Reason: Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.
Code information: Product Code: 53130 01 (105313001), Lot numbers: SM52741 and SM52721.
Distribution pattern: CA, FL, GA, IA, IN, LA, MA, MN, MT, NM, OR, TX and UT.
Derived failure modes
-
Unknown
Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.