FDA recall Z-2911-2020

C.A. Greiner & Sohne Gesellschaftmbh · Class II · 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.

Reason for recall

Sample leaking from the sleeve covering the needle inside the cannula

Distribution

US Nationwide distribution including in the states of UT, TN.

Key facts

Status
Ongoing
Initiation date
2020-07-27
Report date
2020-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Kremsmunster, N/A, Austria

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2911-2020