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5/10 Weck Vista" Universal Balloon Open Access Port -… recallZ-1286-2014 · Teleflex Medical · initiated Mar 11, 2014

Class II Terminated All recalls posted in March 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Complaints were received of leakage of insufflation gas through the device, which can cause difficulty or delay in the completion of laparoscopic surgical procedures.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Recall details

Recall number
Z-1286-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 11, 2014
Posted by the FDA
Mar 25, 2014
Recalling firm
Teleflex Medical
Quantity
55,521 ea. in total
Product code
GCJ
FDA submissions
K112456
Distribution
Worldwide Distribution - USA Nationwide including Puerto Rica and the countries of: Australia, Brazil, China, Canada, Malaysia, Korea, Ireland Singapore and Vietnam.

Product description

5/10 Weck Vista" Universal Balloon Open Access Port - Standard Length (70mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.

Code information (models, lots, serial numbers)

Product Code: 405912RC, Lot Numbers: 01G1200244, 01M1200020, 01M1200068, 01A1300546, and 01A1300559.

Other devices under the same FDA submission

2 devices cleared under K112456 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 67710).

Sources and updates

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