FDA Recall Terminated

BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.

Recall: Z-2274-2013 · Initiated August 23, 2013

Recall

Recall Number
Z-2274-2013
Event Number
66070
Firm
Becton Dickinson & Company
FEI Number
2243072
Product Code
CAZ
Status
Terminated
Root Cause
Unknown/Undetermined by firm
Initiated
August 23, 2013
Posted
September 26, 2013
Terminated
March 19, 2014
Address
1 Becton Dr, Franklin Lakes, NJ, 07417-1815

Description

BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.

Reason

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

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.

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..

Quantity

1,335,885 units