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Recall Observatory FDA recall evidence

Device product

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.

Z-2558-2014

August 01, 2014

Class II

Product summary

Firm
Civco Medical Instruments Inc
Event
Event 68951
Status
Terminated
Classification
Class II
Quantity
52 kits
Official record key
device-enforcement:Z-2558-2014

Official wording

Reason: A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.

Code information: Lot numbers: M431760, M431710, M426580, M430200, M423010

Distribution pattern: Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging of the recalled product potentially could compromise the sterility