Events

Recall of Weck Hemolok XL Polymer Ligating Clips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35316
  • Event Risk Class
    Class 2
  • Event Number
    Z-1098-06
  • Event Initiated Date
    2006-04-12
  • Event Date Posted
    2006-06-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45876
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Polymer Ligating Clips - Product Code FZP
  • Reason
    The hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.
  • Action
    Teleflex Medical sent Important Product Safety Information letters dated 4/18/06 to all of their customers who have purchased Hem-o-lok Ligating Clips from Teleflex. The letters informed the healthcare providers that Teleflex has been made aware of incidents in which the ligating clips (sizes L and XL) were reported to have become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Although none of the incidents appear to have involved any defect in or malfunction of the ligating clips, misapplication of the Hem-o-lok clips during such laparascopic procedures may not immediately be apparent and can have serious, even life-threatening consequences post-operatively. Therefore, Teleflex has added the following contraindication to the Instructions for Use accompanying the Hem-o-lok Polymer Ligating Clips: 'Contraindications': Hem-o-lok ligating clips are contraindicated for use in ligating the renal artery during laparoscopic nephrectomies in living donor patients. 'Caution': The clip must be latched to ensure proper ligation of the vessel or tissue. Inspect the ligation site after application to ensure proper closure of the clip. Security of the closure should be confirmed after ligation. The Hem-o-lok Polymer Ligating Clip is not designed for use as a tissue marker. Weck recommends that more than one clip be used to ligate the renal artery in procedures other than laparoscopic donor nephrectomy (see Contraindication, above). Application of more than one clip to all other vessels should be left to the surgeon's judgment.' Any questions concerning the letter were directed to Teleflex Medical at 800-334-9751, option #7, then option #5. Teleflex sent follow-up ¿Important Product Correction Notice¿ letters dated 8/2/06 to all of their Hem-o-lok Ligating Clips customers via registered mail on 8/7/06. The letters provide clarification of the 4/18/06 letter, reinforcing that the clips are contraindicated for use in ligating t

Device

Weck Hemolok XL Polymer Ligating Clips
  • Model / Serial
    catalog number 544250, all lots
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Weck Hem-o-lok XL Polymer Ligating Clips; Rx, sterile, extra large size, non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges per sales unit, 12 sales units per case; Mfg. by Weck Closure Systems, Research Triangle Park, NC 27709; REF 544250
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 2345 Waukegan Rd Ste 120, Bannockburn IL 60015-1580
  • Source
    USFDA