FDAFDA · Food and drugs·Recall number Z-1285-2014
5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Published April 2, 2014 · Recall initiated: March 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.
- Lot
- Product Code: 405912R, Lot Numbers: 01H1200064, 01K1200378, 01K1200621, 01L1200370, 01M1200071, 01M1200252, 01A1300170, 01A1300201, 01A1300420, 01A1300545, and 01F1300136.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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