greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in
FDA device recall Z-1583-2023 · posted 2023-05-12 · Completed
Recall details
- Recalling firm
- Greiner Bio-One North America, Inc.
- Reason for recall
- Some of the tubes may be incorrectly labeled.
- Action taken
- The recalling firm issued a letter dated 3/30/2023 on 3/31/2023 via email to their sole customer. The letter provided the reason for recall, contained detailed information regarding the complaint, provided photographs of the product which included incorrect tube labels and correct tube labels, investigation results, health risk analysis, and actions to be taken. Those actions included to discontinue use of the product immediately and isolate it, assess the risks and consequences of the use of the defective product in accordance with the customer's procedures and take appropriate action, and complete the attached Product Disposition Site Confirmation. The customer is to record the amount of product they have destroyed on the form and return it via FAX or email. It also instructs that if the customer has distributed this product elsewhere, they are requested to provide the recalling firm with the contact information for follow-up.
- Root cause
- Labeling Change Control
- Status
- Completed
- Product code
- JKA
- Quantity affected
- 36,000 pieces (30 full cases)
- Distribution
- US Nationwide distribution in the states of WI and GA.
- Date initiated
- 2023-03-31
- Date posted
- 2023-05-12
- Location
- Monroe, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 (K960860) | Greiner America, Inc. | 1996-09-05 |