BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in c

FDA device recall Z-2274-2013 · posted 2013-09-26 · Terminated

Recall details

Recalling firm

Becton Dickinson & Company

Reason for recall

BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick within the syringe preventing the user from detecting a loss of resistance upon entering the epidural space.

Action taken

BD sent a product advisory notice to distributors/customers dated August 23, 2013 via UPS 2nd day mail. Consignees will be contacted by phone email and letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to be aware of the issue with the product and to follow the standard routine procedure to ensure that there is no resistance in the syringe prior to use. Any syringe that shows sticking or stalling should be discarded. Customers who distributed this product, should identify their customers and notify them at once of the product advisory. Customers with questions were instructed to call BD Customers Service at 1-800-237-2762. For questions regarding this recall call 201-847-6800.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

CAZ

Quantity affected

1,335,885 units

Distribution

Worldwide Distribution - USA including FL, VA, TX, NY, IL, AZ, MI, RI, NJ, SC, MO, TN, CA, MN, UT, GA, NE, OH, MD, PA, MT and internationally to Brazil, Australia, Canada, and Puerto Rico..

Date initiated

2013-08-23

Date posted

2013-09-26

Date terminated

2014-03-19

Location

Franklin Lakes, NJ