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 Initiated
- July 27, 2020
- Recall Number
- Z-2911-2020
- Quantity
- 390,000 units
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.
Lot / Code Info
Lot # A19073FK
Root Cause
Device Design
Action Taken
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.