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U.S. Department of Health and Human Services

Class 2 Device Recall CIVCO SurgiTip Transducer Cover, REF 610833

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  Class 2 Device Recall CIVCO SurgiTip Transducer Cover, REF 610833 see related information
Date Initiated by Firm February 26, 2015
Date Posted April 08, 2015
Recall Status1 Terminated 3 on February 28, 2017
Recall Number Z-1400-2015
Recall Event ID 70719
510(K)Number K013721  
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only.

The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.
Code Information Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01
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		 Leaks were detected in the recalled lot which may compromise the sterility of the product.
FDA Determined
Cause 2		 Process design
Action On 3/12/2015, the Urgent Medical Device Recall notice was emailed to all of the affected customers. The notice identified the affected product and stated that the sterile covers from the affected manufacturing lot were not meeting quality levels and may leak. Customers were requested to return all of surgi tip covers from the production lot identified for replacement. To schedule the return and arrange for replacement product to be sent, customers were asked to contact Ms. Amy King, Customer Service Team Leader at 319-248-6520 or info@civco.com.
Quantity in Commerce 120 pouches
Distribution Distributed to the states of CA, IL, MA, MI, MO, and WI.
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.
510(K) Database 510(K)s with Product Code = ITX and Original Applicant = CIVCO MEDICAL INSTRUMENTS CO., INC.
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