Class 2 Device Recall BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm)

• Date Initiated by Firm: November 18, 2020
• Create Date: December 15, 2020
• Recall Status: Terminated on February 15, 2024
• Recall Number: Z-0588-2021
• Recall Event ID: 86857
• 510(K)Number: K021475
• Product Classification: Needle, hypodermic, single lumen - Product Code FMI
• Product: BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm); REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin.
• Code Information: Catalog Ref No.: 305106 Lot No:. 9128897 Expiration Date: 2024-06-30 UDI: 30382903051060 Product Package Size: 100 units per carton
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Gail Griffiths; 410-316-4054
• Manufacturer Reason for Recall: BD has confirmed the presence of blood on the cannulas of the BD PrecisionGlide needles 30G X 1/2" Lot No. 9128897. The possibility of infection may be present if the blood is not noticed prior to use by the clinician.
• FDA Determined Cause: Under Investigation by firm
• Action: Customers are provided with the following actions to take in the firm's recall notification letter: 1. Immediately review your inventory for the specific Catalog (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 within or outside your facility network to which you may have further distributed the affected product to ensure they are also aware of this recall. 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 per FDA requirements and subsequently process your product replacement. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 Replacements will be provided for all discarded inventory. If you require further assistance, please contact: BD Contact: Customer/Technical Support US Contact Information: (844) 823-5433 MonFri 8:30am and 5:00pm (EST) Areas of Support: For customers outside the US, contact your local BD representative or distributor
• Quantity in Commerce: 1,430,000
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of CA, CT, FL, IL, KY, MO, NJ, NY, OH, PA, PR, SC, TN, VA and the countries of Canada, China, Singapore.
• 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 = FMI and Original Applicant = BD