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Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm)… recallZ-0771-2014 · Teleflex Medical · initiated Dec 19, 2013

Class II Terminated All recalls posted in January 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

Sterility cannot be guaranteed.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Consignees were notified via letter on 12/19/2013. They were instructed to, immediately discontinue use and quarantine any products with the catalog numbers listed above. Consignees are to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. If they have no affected stock, they were to complete the enclosed Recall Acknowledgment Form and fax it to Teleflex Medical Customer Service. Distributors were instructed to communicate this recall to any of their customers who have received product.

Recall details

Recall number
Z-0771-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 19, 2013
Posted by the FDA
Jan 15, 2014
Recalling firm
Teleflex Medical
Quantity
17,450 ea
Product code
GEI
FDA submissions
K881413
Distribution
Nationwide Distribution.

Product description

Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with Stylet, Teleflex Medical, Research Triangle, NC 27709. Intended to remove tissue and control bleeding by use of high-frequency electrical current.

Code information (models, lots, serial numbers)

Catalog Number: 809610, Lot Number: 01A1100610.

Other devices under the same FDA submission

2 devices cleared under K881413 — 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 67129).

Sources and updates

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