To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
- Recall Initiated
- March 31, 2023
- Posted
- May 19, 2023
- Recall Number
- Z-1616-2023
- Quantity
- 1297 (Boxes; 5 per Box)
- Firm Location
- Center Valley, PA
Reason for Recall
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Distribution
Natiowide Foreign: Canada, Germany
Lot / Code Info
UDI: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937
Root Cause
Employee error
Action Taken
Olympus issued Urgent Medical Medical Device Recall letter on 3/31/23 to Endoscopy Department, Pulmonology Department; Risk Management. . Letter states reason for recall, health risk and action to take: 1. Immediately locate any affected products listed in this communication and quarantine these products. 2. Contact our Olympus Customer Service Team at 1-800-848-9024, option 2. 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 upon return of affected product. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. " Go to https://olympusamerica.com/recall and enter the recall number 0422 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints, including patient injuries and adverse events, to Olympus. Please report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, to report complaints