FDA Recall Terminated

BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277

Recall: Z-2078-2020 · Initiated February 26, 2020

Recall

Recall Number
Z-2078-2020
Event Number
85334
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
LJS
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
February 26, 2020
Terminated
September 22, 2020
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

BARD MYPICC KIT 5F Dual-Lumen, Catalog Number CK000277

Reason

The kits contain surgical gowns which were subject to a recall by the supplier.

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.

Distribution

The products were distributed to the following US states: IN, MO, OH, and TX.

Quantity

1262 total