FDAFDA · Food and drugs·Recall number Z-2558-2014
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.
Published September 3, 2014 · Recall initiated: August 1, 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
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Civco Medical Instruments Inc
- Distributor
- Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.
- Lot
- Lot numbers: M431760, M431710, M426580, M430200, M423010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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