Reported Sep 3, 2014 · Terminated
CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number…
Civco Medical Instruments Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Civco Medical Instruments Inc · 102 1st St S · Kalona, IA · 52247-9589
Is this the product you have?
- 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.
- Lot codes and dates
- Lot numbers
M431760M431710M426580M430200M423010
- Lot numbers
- Amount recalled
- 52 kits
Where it was sold
Why it was recalled
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
This product could cause temporary or reversible health problems — stop using it.
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