Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Opt
FDA device recall Z-1470-2013 · posted 2013-06-05 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity
- Action taken
- Covidien sent an Urgent Medical Device Recall letter dated May 6, 2013,via federal express to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the product and return all inventory to Covidien Surgical Solutions, 195 McDermott Road, North Haven, CT 06473. Customers were requested to return completed Response Form. Customers with questions were instructed to contact their Covidien representative or Covidien Customer Service, Monday through Friday, Sam - 6:30pm ET, at (800) 962-9888, option 1, and then option 2. For questions regarding this recall call 203-492-8165.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 5364 units
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to the following countries: Canada Austria Bahrain Benoni Centurion Chatsworth Czech Republic Denmark Egypt Finland France Germany Ireland
- Date initiated
- 2013-05-06
- Date posted
- 2013-06-05
- Date terminated
- 2014-08-12
- Location
- North Haven, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR (K112349) | Covidien, Formerly US Surgical A Divison of Tyco H | 2011-09-01 |