| Class 1 Device Recall BD Vacutainer EDTA Tubes | |
Date Initiated by Firm | March 22, 2018 |
Date Posted | March 22, 2018 |
Recall Status1 |
Terminated 3 on July 25, 2022 |
Recall Number | Z-1139-2018 |
Recall Event ID |
79223 |
510(K)Number | K981013 |
Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
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Product | BD Vacutainer EDTA Lavender Top Tubes: Catalog Numbers: 1. 366401 (UDI: 50382903664011); 2. 366450 (UDI: 50382903664509); 3. 366643 (UDI: 50382903666435); 4. 367835 (UDI: 50382903678353); 5. 367841 (UDI: 50382903678414); 6. 367844 (UDI: 50382903678445); 7. 367856 (UDI: 50382903678568); 8. 367861 (UDI: 50382903678612); 9. 367862 (UDI: 50382903678629); 10. 367863 (UDI: 50382903678636); 11. 368021 (UDI: 50382903680219); 12. 368047 (UDI: 50382903680479); 13. 368054 (UDI: 50382903680547); 14. 368661 (UDI: 50382903686617); 15. 364300 (UDI: pre-UDI) |
Code Information |
All lots. Catalog Number (Shelf Life): 1. 366401 (24 months); 2. 366450 (24 months); 3. 366643 (12 months); 4. 367835 (16 months); 5. 367841 (15 months); 6. 367844 (16 months); 7. 367856 (16 months); 8. 367861 (16 months); 9. 367862 (16 months); 10. 367863 (17 months); 11. 368021 (16 months); 12. 368047 (15 months); 13. 368054 (16 months); 14. 368661 (17 months); 15. 364300 (Requested) |
Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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For Additional Information Contact | 201-847-6800 |
Manufacturer Reason for Recall | BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology. |
FDA Determined Cause 2 | Device Design |
Action | On March 22, 2018, BD issued a press release. BD intends to distribute URGENT MEDICAL DEVICE CORRECTION notices to their customers in the upcoming days via courier service. The URGENT MEDICAL DEVICE CORRECTION notification has been posted on BD's website along with a link to their press release. BD has updated the IFU for BD Vacutainer EDTA and BD Vacutainer Lithium Heparin Tubes to include the noted precaution for use of Lavender, Tan, Pink and Green Top tubes on Magellan Diagnostics Leadcare assays using ASV methodology.
**Distributors are advised to Take the Following Actions:
1) This is a Medical Device Correction and there is no need to return or discard product. The product can continue to be used with other non-ASV blood lead level test technologies such as GFAAS and ICP-MS and all assays which do not employ ASV methodology.
2) If you have distributed this product, please identify your customers and notify them of this recall by sharing a copy of the correction notice.
3) Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the covered product.
4) If you would like BD to conduct the notification to your customers, please email your customer list within 3 business days to BDPASRC@bd.com. Please include the contact name, address, phone number, email address, and/or fax numbers for each customer.
Distributors who require further assistance, please contact BD at 1-888-237-2762 (select Option #3 and then Option # 4) between 8AM and 5 PM, CT Monday through Friday.
**Medical Directors, Risk Managers, Medical Device Safety Officers & Lab Managers are advised to Take the Following Actions:
1) This is a Medical Device Correction and there is no need to return or discard product. The product can continue to be used with other non-ASV blood lead level test technologies such as GFAAS and ICP-MS and all assays which do not employ ASV methodology.
2) Continue to follow FDA's safety |
Quantity in Commerce | 1,116,012,050 |
Distribution | Distributed in 46 states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Puerto Rico. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JKA
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