ClearanceBrief
Recall Z-0295-2013 ยท LYZ Vinyl Patient Examination Glove

Gulf South Medical Supply Inc

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.

DateNov 15, 2012 (initiated Jun 20, 2012)
StatusTerminated
ReasonGulf 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.
Root causeEmployee error
ActionThe 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
Quantity275 cases and 17 boxes
DistributionNationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K102152POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
Hebei Tengda Plastic Co., Ltd., Apr 28, 2011