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Recall Observatory FDA recall evidence

Device product

Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.

Z-0758-2017

November 10, 2016

Class II

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

    reason.no_named_rule · v1.0.0

    Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.