The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Shea
FDA device recall Z-0151-06 · posted 2005-11-16 · Terminated
Recall details
- Recalling firm
- Applied Medical Resources Corp
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 117 Units
- Distribution
- Nationwide
- Date initiated
- 2005-10-17
- Date posted
- 2005-11-16
- Date terminated
- 2008-04-24
- Location
- Rancho Santa Margarita, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LAPAROSCOPIC HAND PORT (K003871) | Applied Medical Resources Corp. | 2001-05-31 |