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U.S. Department of Health and Human Services

Class 2 Device Recall BARD MYPICC KIT

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  Class 2 Device Recall BARD MYPICC KIT see related information
Date Initiated by Firm February 26, 2020
Create Date May 21, 2020
Recall Status1 Terminated 3 on September 22, 2020
Recall Number Z-2077-2020
Recall Event ID 85334
510(K)Number K091324  
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product BARD MYPICC KIT 4F Single-Lumen, Catalog Number CK000276
Code Information Lot Numbers: 18JBB605 18KBZ117 19EBE196 19GBG860 19SBH077 19UBA090
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
800-290-1689
Manufacturer Reason
for Recall		 The kits contain surgical gowns which were subject to a recall by the supplier.
FDA Determined
Cause 2		 Under Investigation by firm
Action URGENT: MEDICAL DEVICE RECALL notification letters dated 2/26/20 were sent to customers. YOU NEED TO TAKE THE FOLLOWING ACTIONS: 1. Immediately examine your inventory for the product code and lot numbers listed in Attachment A. Quarantine any unused product subject to this recall. Immediately discontinue the use and distribution of the affected kits. Please share this recall notification with all users of the product to ensure they are also aware of the recall. 2. Please complete the attached Business Response Form and fax to: 1-312-949-0230 or email the completed form to BDRC6@bd.com. 3. BD will contact you to provide instructions for returning impacted product kits and for obtaining credit upon receipt of the response form. 4. If you have further distributed this product, please identify your customers and inform them of this notification at once. You may include a copy of this letter in your notification to your customers. NOTE: If you do not have any of the affected lots in your inventory, please complete the Recall Response Form indicating you have zero (0) quantity and return the completed form so that BD receives an acknowledgement of your receipt of this recall notification. Actions Taken by BD: ¿ BD will provide credit for the returned recalled product and will work with you to place orders for alternate devices. Contact Information: If you have any questions or require assistance with the return of the recalled product, please contact BD at 1-800-290-1689 between 8 AM and 5 PM MST Monday through Friday.
Quantity in Commerce 1262 total
Distribution The products were distributed to the following US states: IN, MO, OH, and TX.
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 = LJS and Original Applicant = C.R. BARD, INC.
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