Z-2911-2020Class II

Plastic Cannula HOLDEX Item # 450216 -

Name: Z-2911-2020 Plastic Cannula HOLDEX Item # 450216 -
Creator: C.A. Greiner & Sohne Gesellschaftmbh
Published: 2020-07-27
License: https://open.fda.gov/license/

C.A. Greiner & Sohne Gesellschaftmbh / initiated 2020-07-27 / Open, Classified / root cause: design

FDA source

C.A. Greiner & Sohne Gesellschaftmbh began a recall of Plastic Cannula HOLDEX Item # 450216 - Product Usage: - Product Usage: It is intended for use in routine specimen withdrawal from specimen collection bags or... on 2020-07-27. FDA classified it as Class II and gives the reason as "Sample leaking from the sleeve covering the needle inside the cannula". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2911-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-27
Posted: 2020-08-28
Recalling firm: C.A. Greiner & Sohne Gesellschaftmbh
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.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Sample leaking from the sleeve covering the needle inside the cannula
Root cause tag: design
FDA root cause: Device Design
Action: On July 27, 2020 Greiner issued a product recall notification to their distributors. It states the following actions to be taken: 1. Stop distributing the product (concerned item/lot) immediately and isolate defective products in your facility. Complete the attached Product Disposition form and fax it to Greiner at 800.726.0052 or email to [email protected]. Greiner will contact you for the return or destruction of the product after receiving the attached Product Disposition Site Confirmation form. Greiner will also use this information to send you replacement stock or issue a credit. 2. Greiner requesting to provide them with a list of your customers that have received the item with this specific lot number. include: Facility, Address, Key contact, Phone number, Fax, and Date shipped. If you have additional questions, please call Technical Service at 800-515-8112. Actions to be taken by Laboratory Director, Recall Coordinator or Medical Safety Officer: 1. Stop using the product (concerned item/lot) immediately and isolate defective products in your facility. 2. Assess risks and consequences for the use of this defective product in accordance with your procedures and take appropriate action. 3. Complete theProduct Disposition Site Confirmation form and fax to Greiner Bio-One North America, Inc. at 800.726.0052 or email to [email protected]. This form is to confirm that you have discarded/destroyed all products from this item/lot. We will replace the product after the completed form is sent to Greiner. If you have additional questions, please call Technical Service at 800-515-8112.
Quantity in commerce: 390,000 units
Distribution: US Nationwide distribution including in the states of UT, TN.
Product codes and lots: Lot # A19073FK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2911-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2911-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-09	2020-08-28

Product code FMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)