Recall Z-2911-2020 ยท FMI Needle, Hypodermic, Single Lumen
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.
| Date | Jul 27, 2020 |
| Status | Open, Classified |
| 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. Grein |
| Quantity | 390,000 units |
| Distribution | US Nationwide distribution including in the states of UT, TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.