Recall Z-1067-2021— 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. FDA's recall record names no specific 510(k) clearance for this event. Product: MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.. 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
Product description
MAJ-244 SINGLE USE 30MM REPLACEMENT BASKET, model no. MAJ-244 - Product Usage: REPLACEMENT BASKET for BML-3Q Mechanical Lithotripter.
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.