BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

FDA device recall Z-0252-2020 · posted 2019-10-31 · Terminated

Recall details

Recalling firm

Becton Dickinson & Company

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.

Action taken

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

Status

Terminated

Product code

FMI

Quantity affected

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.

Date initiated

2019-03-07

Date posted

2019-10-31

Date terminated

2022-02-11

Location

Franklin Lakes, NJ

Related 510(k) clearances