Recall Z-0151-06 ยท GCJ Laparoscope, General & Plastic Surgery
Applied Medical Resources Corp
The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubricant, and Incision Template.
| Date | Nov 16, 2005 (initiated Oct 17, 2005) |
| Status | Terminated |
| Reason | The Applied GelPort Laparoscopic Hand Access Device, Model C8004. product is being recalled due to an incorrect component. The incorrect Wound Retractor base was packaged with the kit. |
| Root cause | Process control |
| Action | The recall was initiated on October 14,2005. Applied Medical will contact all customers involved in the recall via overnight FEDEX / UPS. A follow-up communication concerning the recall notification letter will be sent to each of the customers who have not responded with 30 days.Applied is requesting product lot listed in the notification be returned to Applied Medical. All product involved in the recall will be destroyed. |
| Quantity | 117 Units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003871 | LAPAROSCOPIC HAND PORT Applied Medical Resources Corp., May 31, 2001 |