Device product
TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 15G x 79mm
Z-2249-2021
Product summary
- Event
- Event 88314
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,200 device
- Official record key
device-enforcement:Z-2249-2021
Official wording
Reason: Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Code information: Catalog Number/UDI: TIN3018/(01)10885403043819(17)241031(10)0001330956; TIN3015/(01)10885403043796(17)241031(10)0001331229; Serial Numbers: 0001330956; 0001331229;
Distribution pattern: U.S Nationwide Distribution in the states of .: AZ, CT, DC, FL, IL, MA, MI, MO, NY, OK, TX, and VA O.U.S.: Australia, Belgium, China, EMEA, Japan, Mexico, Saudi Arabia, Singapore, Taiwan
Derived failure modes
-
Labeling or packaging
open packaging