Recall Z-1069-2021— Aomori Olympus Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Aomori Olympus Co., Ltd., initiated 2021-01-04, terminated 2024-03-11. It names one FDA 510(k) clearance: K023272. Product: NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract.. Reason: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used..
- Recalling firm
- Aomori Olympus Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-01-04
- Terminated
- 2024-03-11
- Firm location
- Kuroishi, N/A, Japan
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
NA-200H-8022 22G EZSHOT ASPIRATION NEEDLE, model no. NA-200H-8022 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the gastrointestinal tract.
Reason for recall
Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
Data sourced from openFDA. This site is unofficial and independent of the FDA.