Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2079-2020Class II

BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278

Becton Dickinson & Co / initiated 2020-02-26 / Terminated / root cause: supplier

Becton Dickinson & Company began a recall of BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278 on . FDA classified it as Class II and gives the reason as "The kits contain surgical gowns which were subject to a recall by the supplier". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number
Z-2079-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson & Co
Product
BARD MYPICC KIT 5F Triple-Lumen, Catalog Number CK000278
Product code
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall
The kits contain surgical gowns which were subject to a recall by the supplier.
Root cause tag
supplier
FDA 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 [email protected]. 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.
Product codes and lots
Lot Numbers: 19FBN919 19GBZ466

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2079-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2075-2020Class IITerminatedVoluntary: Firm initiated
Z-2076-2020Class IITerminatedVoluntary: Firm initiated
Z-2077-2020Class IITerminatedVoluntary: Firm initiated
Z-2078-2020Class IITerminatedVoluntary: Firm initiated
Z-2079-2020Class IITerminatedVoluntary: Firm initiated
Z-2080-2020Class IITerminatedVoluntary: Firm initiated
Z-2081-2020Class IITerminatedVoluntary: Firm initiated
Z-2082-2020Class IITerminatedVoluntary: Firm initiated