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U.S. Department of Health and Human Services

Class 2 Device Recall CollectEVAC

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  Class 2 Device Recall CollectEVAC see related information
Date Initiated by Firm August 01, 2014
Date Posted August 28, 2014
Recall Status1 Terminated 3 on January 28, 2015
Recall Number Z-2558-2014
Recall Event ID 68951
Product Classification Evacuator, gastro-urology - Product Code KQT
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.
Code Information Lot numbers: M431760, M431710, M426580, M430200, M423010
Recalling Firm/
Manufacturer		 Civco Medical Instruments Inc
102 1st St S
Kalona IA 52247-9589
For Additional Information Contact James Leong
319-248-6502
Manufacturer Reason
for Recall		 A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
FDA Determined
Cause 2		 Packaging
Action Civco Medical Instrucments contacted customers by phone and sent an Urgent Medical Device Recall letter dated August 1, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return all the affected product. Customers were instructed to contact Customer Service at 319-248-6520 with any concerns or questions.
Quantity in Commerce 52 kits
Distribution Worldwide Distribution - USA including AZ, IL, MA, MD, MI, MN, MO, MS, LA, NC, NJ, NY, SD, TN, VA, WI, and Internationally to Brazil.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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