||December 19, 2012
|Recall Event ID
Syringe, piston -
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.
||Device Listing Number - R060456
REF Lot #
Becton Dickinson & Company
1 Becton Dr
|For Additional Information Contact
||Mr. Greg Morgan
|BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.
|Mixed-up of materials/components
||Becton Dickinson sent a Urgent Product Recall letter/Customer Packing list dated October 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to review inventory and determine if they have any of the affected product. If so, it should be removed from inventory.
The enclosed customer list should be completed as well. Any questions please call 1-201-847-4267.
|Quantity in Commerce
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = FMF and Original Applicant = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC