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U.S. Department of Health and Human Services

Class 2 Device Recall Vinyl PowderFree Exam Gloves

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 Class 2 Recall
Vinyl PowderFree Exam Gloves
see related information
Date Posted November 15, 2012
Recall Status1 Terminated on August 19, 2014
Recall Number Z-0295-2013
Recall Event ID 63603
Premarket Notification
510(K) Number
K102152 
Product Classification Vinyl Patient Examination Glove - Product Code LYZ
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.
Code Information Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635.
Recalling Firm/
Manufacturer
Gulf South Medical Supply Inc
4345 Southpoint Blvd
Jacksonville, Florida 32216-8013
For Additional Information Contact Gulf South Customer Care
800-347-2456
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
TRAINING: Employee Error
Action The firm, PSS World Medical, sent an "URGENT RECALL NOTICE" dated June 20, 2012 via USPS to all customers that received the product. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, quarantine the affected lot numbers listed in this recall and return the product; If the product was further distributed, to inform their customers of the recall and request they return the affected product directly to them; and contact their Gulf South Customer Care team via telephone at 1-800-347-2456 or email to customercare@gsms.com to request a return goods authorization. If you have any questions, contact the Product Integrity Leader Quality Assurance at 904-380-4501.
Quantity in Commerce 275 cases and 17 boxes
Distribution Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LYZ and Original Applicant = HEBEI TENGDA PLASTIC CO., LTD
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