PlainRecordsFDA · Medical device recall
Surgical Clamp Inserts… and 2 more products
- Date posted by the FDA
- Aug. 11, 2011
- Status
- Terminated
- Filed by
- Applied Medical Resources Corp
- 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.
- Distribution pattern
- 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.
3 products in this recall
Surgical Clamp Inserts…
- Product
- 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.
- Quantity
- 20,247 units total
- Codes and lots
- 1114700,1117956,1122073,1128221, 1130157,1133116
- Recall started
- March 7, 2011
- Device type
- Clamp, Vascular
- Root cause (FDA)
- Other
- What the company told customers
- 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, were instructed to contact the Sales Operations Administrator, at (949) 713-8652 or by email at cjacobson@appliedmedical.com. Customers with regulatory questions, were instructed to contact the Director, Regulatory Affairs, at (949) 713-8041 or by e-mail at sfehrenbacher@appliedmedical.com.
- Recall number
- Z-3004-2011
Surgical Clamp Inserts…
- Product
- Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 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.
- Quantity
- 20,247 units total
- Codes and lots
- 1112662,1115821,1121413,1122062, 1122163,1125949,1129996,1130225, 1131354
- Recall started
- March 7, 2011
- Device type
- Clamp, Vascular
- Root cause (FDA)
- Other
- What the company told customers
- 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, were instructed to contact the Sales Operations Administrator, at (949) 713-8652 or by email at cjacobson@appliedmedical.com. Customers with regulatory questions, were instructed to contact the Director, Regulatory Affairs, at (949) 713-8041 or by e-mail at sfehrenbacher@appliedmedical.com.
- Recall number
- Z-3005-2011
Surgical Clamp Inserts…
- Product
- Surgical Clamp Inserts, Model#G-8655, 86MM Insert Fibra/Fibra 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.
- Quantity
- 20,247 units total
- Codes and lots
- 1115314, 1119397, 1122010, 1122067, 1127490, 1129502, 1130375
- Recall started
- March 7, 2011
- Device type
- Clamp, Vascular
- Root cause (FDA)
- Other
- What the company told customers
- 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, were instructed to contact the Sales Operations Administrator, at (949) 713-8652 or by email at cjacobson@appliedmedical.com. Customers with regulatory questions, were instructed to contact the Director, Regulatory Affairs, at (949) 713-8041 or by e-mail at sfehrenbacher@appliedmedical.com.
- Recall number
- Z-3006-2011
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-3004-2011, Z-3005-2011, Z-3006-2011. The agency record governs; check it and the company before acting.