Class 2 Device Recall 23ga MidField Endo Illuminator, Synergetics

• Date Initiated by Firm: December 09, 2013
• Date Posted: January 30, 2014
• Recall Status: Terminated on March 25, 2015
• Recall Number: Z-0896-2014
• Recall Event ID: 67147
• Product Classification: Photocoagulator and accessories - Product Code HQB
• Product: 23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
• Code Information: Lot number: M270550
• Recalling Firm/ Manufacturer: Synergetics Inc; 3845 Corporate Centre Dr; O Fallon MO 63368-8678
• For Additional Information Contact: Dan Regan; 636-794-5013
• Manufacturer Reason for Recall: Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devices could result in seal failure.
• FDA Determined Cause: Use error
• Action: Domestic customers were sent recall notices by FedEx on December 9, 2013. Foreign customers were sent recall notices by e-mail between December 6 and December 13, 2013. The recall notice instructed customers to return the recalled product.
• Quantity in Commerce: 26 units
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
• Total Product Life Cycle: TPLC Device Report

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.