Recall StatusTerminated
Date Initiated2019-03-07
Date Terminated2022-02-11
Product Quantity2,624,160 (2,169,703 US; 454,457 OUS)
Reason for Recall
BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.
Firm 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-patient needle end of the product.
***END UPDATE***
Customers were asked to take the following actions:
1. Immediately review your inventory for the specific Catalogue (Ref) and lot number listed above. Destroy all product subject to the recall following your institutions process for destruction.
2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall.
3. Complete the attached Customer Response Forms and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement.
The firm stated it would provide replacement for all discarded inventory.
***PUBLIC CONTACT ADDED 7/11/19***
If you have any questions, you may reach BD Customer/Technical Support at 888-237-2762 OPT 3, OPT 2; Monday Friday 8:00am - 5:00pm (CT)
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.