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U.S. Department of Health and Human Services

Class 2 Device Recall BD UltraFine Pen Needles 32G x 4mm

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 Class 2 Device Recall BD UltraFine Pen Needles 32G x 4mmsee related information
Date Initiated by FirmOctober 23, 2020
Create DateNovember 27, 2020
Recall Status1 Terminated 3 on September 08, 2023
Recall NumberZ-0508-2021
Recall Event ID 86679
510(K)NumberK162516 
Product Classification Needle, hypodermic, single lumen - Product Code FMI
ProductBD 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
Code Information Batch Number: 9352052 Exp. Date: 20241231
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactSAME
201-847-6800
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionBD 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
Quantity in Commerce2,881,200 units
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMI
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