FDA Medical Device Recalls (openFDA)
C.A. Greiner & Sohne Gesellschaftmbh: 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.
- Recall number
- Z-2911-2020
- 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.
- Status
- Open, Classified
- Initiated
- 2020-07-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- Sample leaking from the sleeve covering the needle inside the cannula
- 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 patech@gbo.com. 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 patech@gbo.com. 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
- 390,000 units
- Distribution
- US Nationwide distribution including in the states of UT, TN.
- Lot, serial or model codes
- Lot # A19073FK
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 6368
- Firm city
- Kremsmunster
- Firm state
- not on file
- Firm country
- Austria
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28