Z-2911-2020 Class II Ongoing

Recalled by C.A. Greiner & Sohne Gesellschaftmbh — Kremsmunster, N/A

FDA device recall Z-2911-2020 was initiated by C.A. Greiner & Sohne Gesellschaftmbh on July 27, 2020 and is designated Class II. Reason for recall: Sample leaking from the sleeve covering the needle inside the cannula The recall status is ongoing. Affected quantity: 390,000 units.

Recall Details

Product Type
Devices
Report Date
September 9, 2020
Initiation Date
July 27, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
390,000 units

Product Description

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 Pattern

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

Code Information

Lot # A19073FK