Device product
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Z-0846-2022
Product summary
- Event
- Event 89132
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,280 devices (314 cases)
- Official record key
device-enforcement:Z-0846-2022
Official wording
Reason: Product was distributed with incorrect expiration date.
Code information: Finished Product Code: 102005202; Alternate Code: 24014-5; Lot No.: 20065842, 30135996, 30135999, 30137463, 30140309, 30138711, and 30141360.
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
Derived failure modes
-
Unknown
Product was distributed with incorrect expiration date.