Recall Z-3004-2011 ยท DXC Clamp, Vascular
Applied Medical Resources Corp
Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are available in 33, 45, 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws.
| Date | Aug 11, 2011 (initiated Mar 7, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Applied Medical has confirmed that Surgical Clamp Inserts, Model Numbers: G-8600, G-8650, G-8655, has the potential packaging nonconformance which could result in a compromise to the sterile barrier. |
| Root cause | Other |
| Action | The firm, Applied Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 11, 2011 to its customers. The letter provides customers with an explanation of the problem identified and actions to be taken. The customers were instructed to check their inventory; complete and return the attached Voluntary Recall Notification Confirmation Form via fax to Regulatory Affairs at 949-713-8832, and return the recalled Standard 86mm Inserts immediately to Applied Medical, Attn: RGA# 60308783, 22872 Avenida Empresa, Rancho Santa Margarita, CA 92688. Customers with product return questions, we |
| Quantity | 20,247 units total |
| Distribution | Worldwide distribution: USA (nationwide) including states of: Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, and Michigan; and countries of: Japan, Israel, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K883790 | SURGICAL CLAMP INSERTS Applied Vascular Devices, Inc., Dec 27, 1988 |