Recalls / —
—#180555
Product
BARD MYPICC KIT 3F Single-Lumen, Catalog Number CK000417B
- FDA product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K102159
- Affected lot / code info
- Lot Numbers: 18KBN221 18MB9962 18NB2698 19FBK323 19LBB569 19SBH078 19TBD608
Why it was recalled
The kits contain surgical gowns which were subject to a recall by the supplier.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- The products were distributed to the following US states: IN, MO, OH, and TX.
Timeline
- Recall initiated
- 2020-02-26
- Terminated
- 2020-09-22
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #180555. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.