VACUETTE, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of
FDA device recall Z-0215-2009 · posted 2008-11-07 · Terminated
Recall details
- Recalling firm
- Greiner Bio-One North America, Inc.
- Reason for recall
- Labeling Error: Incorrect tube label reads "Z Serum Clot Activator" instead of "LH Lithium Heparin" tube. All other information on the tube label including color coding of tube was correct. Case and rack label information showed the correct information with 2 ml Lithium Heparin.
- Action taken
- Consignees were notified by letter on 07/29/2008. Notification letters to distributors instructed them to stop distribution of the product and destroy all affected lots of the product. In addition, notification letters addressed to users instructed them to destroy and discard all products from the item and affected lots. The "Product Disposition Form" must be completed by the consignee and returned to Greiner Bio-One North America, Inc. For questions or additional information, contact Greiner Bio-One North America, Inc. at 704-261-7800.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JKA
- Quantity affected
- 33 cases (39,600 pieces)
- Distribution
- Worldwide including USA (states of AK, AL, AR, CA, CO, DE, GA, ID, IL, IN, KS, LA, MA, MI, MO, MS, NC, ND, NE, NH, NY, OH, OK, OR, PA, RI, SC, SD, TX, VA, VT, WA, and WI) and country of Canada.
- Date initiated
- 2008-07-29
- Date posted
- 2008-11-07
- Date terminated
- 2009-08-26
- 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 W/LITHIUM HEPARIN & GEL SEPARATOR (K960857) | Greiner America, Inc. | 1996-08-30 |