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Class 2 Device Recall Vinyl PowderFree Exam Gloves |
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Date Initiated by Firm |
June 20, 2012 |
Date Posted |
November 15, 2012 |
Recall Status1 |
Terminated 3 on August 19, 2014 |
Recall Number |
Z-0295-2013 |
Recall Event ID |
63603 |
510(K)Number |
K102152
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Product Classification |
Glove, Patient Examination Vinyl - Product Code LYZ
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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 FL 32216-8013
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For Additional Information Contact |
Gulf South Customer Care 800-347-2456
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = LYZ and Original Applicant = HEBEI TENGDA PLASTIC CO., LTD
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