FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B
- Recall number
- Z-2080-2020
- Recalling firm
- Becton Dickinson & Company
- Product
- BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B
- Status
- Terminated
- Initiated
- 2020-02-26
- Posted
- not on file
- Terminated
- 2020-09-22
- Reason
- The kits contain surgical gowns which were subject to a recall by the supplier.
- Root cause
- 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
- 1262 total
- Distribution
- The products were distributed to the following US states: IN, MO, OH, and TX.
- Lot, serial or model codes
- Lot Numbers: 18KBN221 18MB9962 18NB2698 19FBK323 19LBB569 19SBH078 19TBD608
- 510(k) numbers
- ["K102159"]
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28