Recall Z-0564-2013— Becton Dickinson & Company

Name: FDA recall Z-0564-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-02

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2012-10-02, terminated 2016-05-03. It names one FDA 510(k) clearance: K980987. Product: Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.. Reason: BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2012-10-02
Terminated: 2016-05-03
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K980987 — BECTON DICKINSON SYRINGEBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1998-06-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.

Reason for recall

BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.

Data sourced from openFDA. This site is unofficial and independent of the FDA.