Recall Z-0924-06 ยท GCJ Laparoscope, General & Plastic Surgery
Ethicon Endo-Surgery Inc
Endopath Probe Plus II, Needle Electrode, 5mm shaft, 29cm length, hollow tip electrode, Code EPS09.
| Date | May 31, 2006 (initiated Apr 20, 2006) |
| Status | Terminated |
| Reason | There is the possibility of a seal void in the Probe Plus packaging which may have compromised the sterility of the device. |
| Root cause | Packaging process control |
| Action | The recalling firm sent a recall letter by United Parcel Services to all consignees for delivery to each consignee on 4/24/06. The letter requested subaccount address return information to the recalling firm. |
| Quantity | 24 cases/6 devices per case. |
| Distribution | The recalled product was distributed throughout the United States and to foreign consignees including Argentina, Australia, Austria, Bahrain, Brazil, Canada, China, Colombia, Czech Republic, Dominican Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Ja |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912492 | EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE ETHICON, Inc., Oct 21, 1991 |