FDA Recall Terminated

BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

Recall: Z-0207-2018 · Initiated May 31, 2017

Recall

Recall Number
Z-0207-2018
Event Number
77639
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
FMI
Status
Terminated
Root Cause
Process control
Initiated
May 31, 2017
Terminated
June 28, 2018
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

Reason

Hub damage resulting in breakage and/or leakage during use.

Action

On May 31, 2017 BD distributed Urgent Medical Device Recall notices and Business Response Cards to their customers. Customers were advised to immediately review their inventory for the specific Catalog (Ref) and lot number, discontinue use of and quarantine the affected item. Complete and return the Business Response Card form via fax to BD 855-544-4803 or email the form to [email protected]. Return all affected products with the completed Business Response Card form following the instruction on the enclosed packing instruction. Upon receipt of the returned product, BD will issue product replacement. Note: If customers do not have any of the affected lots in your inventory, please complete the Business Response Card form indicating you have zero (0) quantity. Customers who have questions or require further assistance with the return of the recalled product, please contact 855-215-4932 between 8AM and 5PM, EST, Monday through Friday.

Distribution

Nationwide Distribution

Quantity

2,598,000 units