—#171420

Product

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

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K982541
Affected lot / code info: Lot 8207894 ***UPDATED 7/11/19*** Lots 9025826 and 8354527 ***UPDATED 12/10/19*** Lot 9010765

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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)

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

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.

Timeline

Recall initiated: 2019-03-07
Posted by FDA: 2019-10-31
Terminated: 2022-02-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171420. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.