Z-1061-2020 Class II Terminated
FDA device recall Z-1061-2020 was initiated by Centurion Medical Products Corporation on December 11, 2019 and is designated Class II. Reason for recall: Incomplete seals on the sterile package may compromise the sterility The recall status is terminated (terminated September 4, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- December 11, 2019
- Termination Date
- September 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PICC DRESSING CHANGE KIT
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Distribution Pattern
Nationwide Foreign: GHANA
Code Information
BSICVC1005A CVC DRESSING CHANGE KIT NICU 2018103090 BSIPICC1002A PICC DRESSING CHANGE KIT NICU 2019021390 BSIPICC1003A PICC DRESSING CHANGE KIT 2019041690, 2019030190