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Recall Observatory FDA recall evidence

Device product

Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination.

Z-0295-2013

June 20, 2012

Class II

Product summary

Firm
Gulf South Medical Supply Inc
Event
Event 63603
Status
Terminated
Classification
Class II
Quantity
275 cases and 17 boxes
Official record key
device-enforcement:Z-0295-2013

Official wording

Reason: Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.

Code information: Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635.

Distribution pattern: Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.