Recall Z-1099-06 ยท FZP Clip, Implantable
Teleflex Medical
Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium Polymer Ligating Clips; Rx, sterile, single use, disposable clip applier with medium size, non-absorbable polymer ligation clips; 15 clips per applier, 3 appliers per sales unit, 6 sales units per case; Mfg. by Weck Closure Systems, 2917 Weck Drive, Research Triangle Park, NC 27709; REF 543965
| Date | Jun 9, 2006 (initiated Apr 12, 2006) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| 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 procedur |
| Quantity | 374,760 clips |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021808 | WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER Weck, Aug 14, 2002 |