Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.
FDA device recall Z-0184-2012 · posted 2011-11-14 · Terminated
Recall details
- Recalling firm
- Greiner Bio-One North America, Inc.
- Reason for recall
- Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.
- Action taken
- Consignees were notified by Greiner bio-one letter on August 11, 2011. They were instructed to: Stop distributing the material, complete the product Disposition form attach and to fax it to Greiner bio-one and to destroy or return any of the affected products for replacement or credit. Distributors were asked to provide a list of their customers that have received the item, preferably in an Excel file, so that they could be notified of the recall.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 504,000 pieces
- Distribution
- Nationwide.
- Date initiated
- 2011-08-12
- Date posted
- 2011-11-14
- Date terminated
- 2012-03-12
- Location
- Monroe, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GREINER VACUETTE BLOOD COLLECTION TUBE (K971236) | Greiner America, Inc. | 1997-05-12 |