—#184306

Product

BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K162516
Affected lot / code info: Batch Number: 9352052 Exp. Date: 20241231

Why it was recalled

Product shelf cartons incorrectly labeled as products intended for the Latin American market. Although the product description on the label 32G x 4mm pen needles is correct, information pertinent to users in the US regarding compatibility with specific pen needles is missing.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

BD consignees and distributors notified on October 23, 2020 via hard copy letter sent via Federal Express (FedEx) and/or email, when available. Letter states reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog (Ref) and Lot number specified in this notification and discard all product subject to the recall. 2. Share this recall notification with pharmacy staff at all applicable pharmacy locations and display the letter where it is visible to all to ensure awareness of this recall Distributors are requested to identify their customers and provide BD a customer list. BD will notify these customers via FedEx. 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 impacted material so that BD may acknowledge your receipt of this notification and process your product replacement order, accordingly. 4. This recall is being conducted at the wholesaler/hospital/retail level only. There is no need to notify users who may have already purchased the device, as the product itself is not defective and presents no risk to users. Actions Taken by BD: " Replacement product will be provided for all discarded inventory. Contact Information: If you require further assistance, please contact: BD Contact Information: BD Customer/Technical Support (844) 823-5433 Mon Fri 8:30am - 5:00pm (CST

Recalling firm

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

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2020-10-23
Terminated: 2023-09-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184306. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.