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WECK HemoClip Auto, Rx Only, Sterile, Teleflex Medical… recallZ-0160-2009 · Telefelx Medical · initiated Aug 22, 2008

Terminated All recalls posted in September 2008

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 Telefelx 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

A hole in the sterile unit blister pack was detected that would compromise sterility.

FDA root cause category: Packaging process control

What the company is doing

Consignees were notified via UPS next day on/about August 22, 2008. They were instructed to cease use and distribution and quarantine all affected product immediately. If they have any of the affected product they were instructed to return all it to Teleflex Medical via provided UPS-Ground. An Acknowledgement form was provided to be completed and returned via fax to Teleflex Medical to confirm receipt of the notification and amount of product on hand for return. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks from the second mailing. Consignees also may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Upon return to Teleflex Medical, product will be quarantined, assessed for recall effectiveness, and either reworked or destroyed. Contact Telefex Medical at 1-800-334-9751 ext. 8066 for assistance.

Recall details

Recall number
Z-0160-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 22, 2008
Posted by the FDA
Sep 16, 2008
Recalling firm
Telefelx Medical
Quantity
786036 (total pieces)
Product code
FZP
FDA submissions
K021808
Distribution
Nationwide

Product description

WECK HemoClip Auto, Rx Only, Sterile, Teleflex Medical, RTC, NC 27709. The use of the reusable Teleflex Medical metal ligating clips is transient, invasive and intended for the application of hemostatic clips during general open surgery. Ligation clips are non-absorbable to thermostatically restrict flow of fluids within vessels. Clips are removed from the cartridge and applied in such a manner as to engulf vessels. Teleflex Medical metal ligating clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice. Surgeons should select the size type, and material of the clip based upon their experience, judgment and needs.

Code information (models, lots, serial numbers)

Product Code: 527100, Product Description: HemoClip Auto S/S Medium 200/Box; Product Code: 527200, Product Description: HemoClip Auto Titanium Medium 200/Box and Product Code: 527203, Product Description: HemoClip Auto Titanium Medium 100/Box.

Other devices under the same FDA submission

1 device cleared under K021808 — 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 49452).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page