Class 2 Device Recall BD UltraFine(TM) and UltraFine(TM) II

• Date Initiated by Firm: May 25, 2017
• Date Posted: November 28, 2017
• Recall Status: Terminated on June 27, 2018
• Recall Number: Z-0183-2018
• Recall Event ID: 77415
• 510(K)Number: K024112
• Product Classification: Syringe, piston - Product Code FMF
• Product: BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466; BD Insulin Syringes are intended for the subcutaneous injection of insulin
• Code Information: Lot Numbers: 6291768, 6312558 & 6340590. 8/25/17 Firm notified FDA of recall expansion to include Lot Numbers 6312558 and 6340590.
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Zuleika Sanchez; 201-847-5216
• Manufacturer Reason for Recall: Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle ¿mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle ¿mL 8mm 31G, Cat (Ref) 328468. The shelf carton and case carton are correctly labeled as BD Ultra-Fine needle ¿mL 12.7mm 30G.
• FDA Determined Cause: Labeling mix-ups
• Action: BD sent recall notification letters to all direct consignees (wholesaler, hospital, and retail) on May 25, 2017. BD is requesting wholesalers (distributors) to notify any accounts or additional locations that may have received the recalled product from them. BD gives the option to distributors to provide their customer list to BD if they would like BD to notify their customers. BD is requesting retail pharmacies to notify consumers that may have received the recalled product from them. 8/25/17 Firm notified FDA of recall expansion to include Lot Numbers 6312558 and 6340590. A 2nd notification was sent to consignees in a letter dated Aug 30, 2017 that includes all 3 lots that are in scope of the recall. Most of the direct consignees identified in the first recall action were also identified as affected for the second (expanded) recall action since they received either two or all three recall lots. All affected consignees that received any of the three lots have been combined into one consignee list. These customers will be notified of the expanded recall communication (second recall letter dated Aug 30, 2017). To minimize customer disruption, BD will conduct effectiveness check on the second recall letter only, since it covers the recall action for all three affected lots and combines all affected consignees from both actions (first and second/expanded recall). This will allow us to verify that the affected consignees received the notification and took the necessary actions for all three recall lots without having to contact them multiple times for two different letters that cover the same recall action. Details of the effectiveness are as follows: 1.Letters will be mailed with UPS tracking. The effectiveness check level will be established by the FDA classification letter. 2.A Business Response Card is included with the letter to assist direct consignees in responding to the field action. 3.BD will attempt to contact by phone/email (as applicable) non-respondents
• Quantity in Commerce: 7,839,340 units
• Distribution: Nationwide Distribution including CA, CT, FL, IL, LA, ME, MI, NC, ND, NJ, NY, PA, RI, SC, VA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FMF and Original Applicant = BECTON DICKINSON & CO.