Recall Z-2274-2013 ยท CAZ Anesthesia Conduction Kit
Becton Dickinson & Company
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.
| Date | Sep 26, 2013 (initiated Aug 23, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Unknown/Undetermined by firm |
| 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 |
| Quantity | 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.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.