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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Eclipse

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  Class 2 Device Recall BD Vacutainer Eclipse see related information
Date Initiated by Firm March 07, 2019
Date Posted October 31, 2019
Recall Status1 Terminated 3 on February 11, 2022
Recall Number Z-0252-2020
Recall Event ID 82351
510(K)Number K982541  
Product Classification Needle, hypodermic, single lumen - Product Code FMI
Product BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608
Code Information Lot 8207894 ***UPDATED 7/11/19*** Lots 9025826 and 8354527 ***UPDATED 12/10/19*** Lot 9010765
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Customer/Technical Support
888-237-2762
Manufacturer Reason
for Recall		 BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action 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)
Quantity in Commerce 2,624,160 (2,169,703 US; 454,457 OUS)
Distribution 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.
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 = BECTON DICKINSON VACUTAINER SYSTEMS
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