—#157016

Product

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.

FDA product code: FMI — Needle, Hypodermic, Single Lumen
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K021475
Affected lot / code info: Lot Number: 6152995 Expiration Date: 31-Jul-21

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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 bd4354@stericycle.com. 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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2017-05-31
Terminated: 2018-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.