Z-2491-2020 Class II Terminated
FDA device recall Z-2491-2020 was initiated by Prodimed Plastimed Division on May 27, 2020 and is designated Class II. Reason for recall: Lack of assurance of sterility The recall status is terminated (terminated March 29, 2021). Affected quantity: 180.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- May 27, 2020
- Termination Date
- March 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180
Product Description
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
Reason for Recall
Lack of assurance of sterility
Distribution Pattern
Nationwide
Code Information
All lots within expiry