Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes
FDA device recall Z-0295-2013 · posted 2012-11-15 · Terminated
Recall details
- Recalling firm
- Gulf South Medical Supply Inc
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- LYZ
- Quantity affected
- 275 cases and 17 boxes
- Distribution
- Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.
- Date initiated
- 2012-06-20
- Date posted
- 2012-11-15
- Date terminated
- 2014-08-19
- Location
- Jacksonville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K102152) | Hebei Tengda Plastic Co., Ltd. | 2011-04-28 |