Z-1067-2021 Class II Terminated
FDA device recall Z-1067-2021 was initiated by Aomori Olympus Co., Ltd. on January 4, 2021 and is designated Class II. 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. The recall status is terminated (terminated March 11, 2024). Affected quantity: 7,400,000 (globally); 260,395 (US).
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2021
- Initiation Date
- January 4, 2021
- Termination Date
- March 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,400,000 (globally); 260,395 (US)
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.
Distribution Pattern
US Nationwide distribution.
Code Information
01K, 02K, 04K, 05K, 06K, 07K, 09K, 92K, 93K, 94K, 95K, 97K, 9XK