United StatesOmniTract Surgical Retractor System, identified by 633 firm product codes (for example Product Code 3032, UDI 10381780268468), sold worldwide. It was recalled because the instructions for use state a dry time of 30 minutes but the dry time must be extended to 90, 110, or 120 minutes depending on the sterilization cycle exposure time.
What's being recalled
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Recalling firm: Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States.
How to identify it
Product Code 3032, UDI 10381780268468; Product Code 3055, UDI 10381780268505; Product Code 3069, UDI 10381780268512; Product Code 3076, UDI 10381780268529; Product Code 3086, UDI 10381780268536; Product Code 3092, UDI 10381780268550; Product Code 3093, UDI 10381780268567; Product Code 3096, UDI 10381780268581; Product Code 3098, UDI 10381780268598; Product Code 3099, UDI 10381780268604; Product Code 3133, UDI 10381780268680; Product Code 3137, UDI 10381780268697; Product Code 3142, UDI 10381780268710; Product Code 3146, UDI 10381780268734; Product Code 3148, UDI 10381780268758; Product Code 3176, UDI 10381780268826; Product Code 3177, UDI 10381780268833; Product Code 3185, UDI 10381780268857; Product Code 3201, UDI 10381780268871; Product Code 3203, UDI 10381780268888; Product Code 3216, UDI 10381780268895; Product Code 3217, UDI 10381780268901; Product Code 3218, UDI 10381780268918; Product Code 3219, UDI 10381780268925; Product Code 3220, UDI 10381780268932; Product Code 3274, UDI 10381780268994; Product Code 3312, UDI 10381780269038; Product Code 3335, UDI 10381780269045; Product Code 3336, UDI 10381780269052; Product Code 3342, UDI 10381780269076; Product Code 3343, UDI 10381780269083; Product Code 3391, UDI 10381780269168; Product Code 3398, UDI 10381780269212; Product Code 3424, UDI 10381780269243; Product Code 3426, UDI 10381780269250; Product Code 3483, UDI 10381780269267; Product Code 3485, UDI 10381780269274; Product Code 3520, UDI 10381780282273; Product Code 3529, UDI 10381780269281; Product Code 3530, UDI 10381780269298; Product Code 3531, UDI 10381780269304; Product Code 3532, UDI 10381780269311; Product Code 3533, UDI 10381780269328; Product Code 3534, UDI 10381780269335; Product Code 3535, UDI 10381780269342; Product Code 3536, UDI 10381780269359; Product Code 3537, UDI 10381780269366; Product Code 3555, UDI 10381780269373; Product Code 3557, UDI 10381780269380; Product Code 3565, UDI 10381780269397; Product Code 3570, UDI 10381780269403; Product…
The hazard
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brunei Darussalam, Bulgaria, Canada, Chile, China, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea (the Republic of), Kuwait, Lithuania, Malaysia, Malta, Mauritius, Mexico, Nepal, Netherlands (the), New Zealand, Norway, Pakistan, Palestine, State of, Philippines (the), Poland, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, R¿union, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan (Province of China), Thailand, Trinidad and Tobago, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland, (the), Viet Nam.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)