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.
FDA Recall Z-0295-2013 · Posted 2012-11-15
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Recalling FirmGulf South Medical Supply Inc
Recall StatusTerminated
Product CodeLYZ
Date Initiated2012-06-20
Date Terminated2014-08-19
Product Quantity275 cases and 17 boxes
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.
Firm 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 [email protected] to request a return goods authorization.
If you have any questions, contact the Product Integrity Leader Quality Assurance at 904-380-4501.
Root Cause
Employee error
Distribution Pattern
Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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