U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Instrument, ligature passing and knot tying - Product Code HCF
원인
Incorrect expiration date was printed on the product label.
조치
Teleflex sent an Urgent Medical Device Recall Notification letter dated March 24, 2016, to all affected consignees. The letter requested that consignees check their stock, immediately discontinue use and quarantine any products. To return affected product consignees were instructed to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, ATTN: Customer Service or email to recalls@teleflex.com. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
For questions regarding this recall call 610-378-0131.
Nationwide Distribution to CA, CO, IA, KS, MD, MI, NY, NC, PA
제품 설명
Weck EFx Classic Fascial Closure System, Rx Only, Sterile, || The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery