Recall Z-1096-06 ยท FZP Clip, Implantable
Teleflex Medical
Weck Hem-o-lok ML Polymer Ligating Clips; Rx, sterile, medium 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 544230
| 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 | 3,656,100 clips |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003337 | HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240 Weck Closure Systems, Dec 21, 2000 |