Z-0973-2021 Class II Terminated
FDA device recall Z-0973-2021 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 (global); 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 (global); 260,395 (US)
Product Description
K-204 GUIDE SHEATH Kit 2.6MM, model no K-204 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.
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,03K,04K,05K,06K,07K,08K,09K,95K,96K,97K,98K,99K,9XK,9YK,9ZK