Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Recall
- Recall Number
- Z-1122-2022
- Event Number
- 90009
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- FBN
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 31, 2022
- Terminated
- July 25, 2024
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229
Description
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
Olympus issued "URGENT: MEDICAL DEVICE RECALL" letter on March 28, 2022. Letter states reason for recall, health risk and action to take: 1. Immediately assess any product you have in stock to identify FG-51D forceps with affected lot numbers listed in this communication, cease use of product and quarantine any affected product. The image below depicts the area on the label where the lot number is identified. 2. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility for your affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number 0407 and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please notify your customers of this corrective action immediately. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please do not hesitate to contact your Corrective Actions Lead, Americas directly at 647-999-3203 or at [email protected].
US Nationwide Distribution
1386 units