FDAClass IIApril 9, 2014

5/10/12 mm x 100mm Weck Vista Universal Cone Open recall

5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access…

Why was 5/10/12 mm x 100mm Weck Vista Universal Cone Open recalled?

Complaints of leakage of insufflation gas through the device.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots - Catalog No. 405933 - 01L1200353, 01F1300080

Product
5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access…
Recalling firm
Teleflex Medical
Quantity
55,521 total
Distribution
Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, ND, OH, OR, PA, SC, TN, UT, VA, WA, WV, WI and the countries of Australia, Brazil, Canada, China, Israel, Korea, Malaysia, Singapore, and Vietnam.
Recall date
April 9, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls