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U.S. Department of Health and Human Services

Class 2 Device Recall Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc.

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  Class 2 Device Recall Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. see related information
Date Initiated by Firm December 09, 2013
Date Posted January 30, 2014
Recall Status1 Terminated 3 on March 25, 2015
Recall Number Z-0895-2014
Recall Event ID 67147
Product Classification Photocoagulator and accessories - Product Code HQB
Product Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Code Information Lot numbers: M260800, M262050, M263140, M264420, and M267440
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 2		 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 507 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.
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