Recall Z-0252-2020 ยท FMI Needle, Hypodermic, Single Lumen
Becton Dickinson & Company
BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
| Date | Oct 31, 2019 (initiated Mar 7, 2019) |
| Status | Terminated |
| Reason | BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage. |
| Root cause | Nonconforming Material/Component |
| Action | On March 7, 2019, the firm distributed Urgent Medical Device Recall letters to customers. Customers were informed of the missing bevel, which may ultimately cause leakage if the needle damages the sleeve. ***UPDATED 7/11/19*** In July 2019, the firm sent out an additional notice, informing customers that two additional lots of the product were found to also be affected by the recall. ***UPDATED 12/10/19*** ON 12/4/19, the firm sent out a second expansion letter, informing that customers that an additional lot of product (lot 9010765) was also found to be missing the bevel from the non-pati |
| Quantity | 2,624,160 (2,169,703 US; 454,457 OUS) |
| Distribution | Distributed to accounts in AR, CT, FL, IL, IN, MI, MO, MS, NY, OH, TN, TX, and VA. Foreign distribution to Canada, Brazil, India, Mexico, Singapore, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982541 | VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 Becton Dickinson Vacutainer Systems, Oct 28, 1998 |