Device product
Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports.
Z-2911-2020
Product summary
- Event
- Event 86128
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 390,000 units
- Official record key
device-enforcement:Z-2911-2020
Official wording
Reason: Sample leaking from the sleeve covering the needle inside the cannula
Code information: Lot # A19073FK
Distribution pattern: US Nationwide distribution including in the states of UT, TN.
Derived failure modes
-
Unknown
Sample leaking from the sleeve covering the needle inside the cannula