Device product
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Z-0847-2022
Product summary
- Event
- Event 89132
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,520 devices (126 cases)
- Official record key
device-enforcement:Z-0847-2022
Official wording
Reason: Product was distributed with incorrect expiration date.
Code information: Finished Product Code: 102007202; Alternate Code: 240168-5; Lot No.: 30135997, 30137462, 30138710, 30140310, and 30141359.
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.