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U.S. Department of Health and Human Services

Class 2 Device Recall BD Epilor Syringe

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  Class 2 Device Recall BD Epilor Syringe see related information
Date Initiated by Firm August 23, 2013
Date Posting Updated September 26, 2013
Recall Status1 Terminated 3 on March 19, 2014
Recall Number Z-2274-2013
Recall Event ID 66070
Product Classification Anesthesia conduction kit - Product Code CAZ
Product 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.
Code Information 510K K925902, D041521

Catalog Number: 405198, Lots, 8310086, 9246684, 0035495, 0053165, 0056608, 0056607, 0096757, 0120074, 0126127, 0152581, 0242475, 0258468, 0258469, 0258472, 0291220, 0291221, 0291223, 0291224, 0278495, 0291218, 0291219, 0291222, 0291226, 0291227, 0291228, 0336391, 0336393, 0336396, 0336400, 1005321, 1006136, 1033177, 1033178, 1094304, 1209634, 1210646, 1213990, 1213993, 1276782, 1307383, 2032802, 2033712, 2060835, 2065940, 2084318, 2121011, 2122467, 2205098, 2212313, 2276066, 3038272, 3042376, 3063436, 3063440, 3085498, 3085001, 3085003, 3085005, 3123462, 3123246, 3184092





, Catalog Number 405291, Lots, 0154661, 0174905, 0252565, 0279140, 0301813, 0347866, 1012200, 1035046, 1063738, 1095340, 1124755, 1180073, 1213029, 1262268, 1273795, 1312116, 1320204, 1356378, 2041210, 2058524, 2083246, 2135469, 2158092, 2170207, 2194139, 2205106, 2223162, 2223337, 2250088, 2286395, 2303137, 2303141, 2334338, 2334339, 2355389, 2355391, 3057376, 3120039



Catalog Number 405807, Lots, GD873422, GD874743, GD875419, GD876029, GD876912, GD879577, GD881128, GD883033



Catalog Number 405823, Lots, GD877068, GD882951, GD884312, GD885491, GD886192, GD887893, GD889527, B01F223D, B01F243D, B01G057D, B01G196D

, Catalog Number 406078; , Lots, GD876003, GD877787, GD881169, GD883017, GD883660, GD885202, GD886283, GD888677, GD890442, B01F054D, B02F156D, B02F178D, B03F074D, B03F241D



, Catalog number 406084, Lots, B03F090D, B06F326D, GD875369, GD880427, GD883025, GD888255, B05G087D



, Catalog # 406119, Lots, GD873364, GD875625, GD877878, GD879015, GD881813, GD885129, GD889782, B02F051D, B02F096D, B01F135D, B03F222D

Catalog # 406121, Lots, GD887596, GD889618



Catalog # 406156, Lots, GD887778, GD889733, GD889980, GD890178, B02F214D, B02F292D, B02G157D, B03F292D, B03G158D, B04F238D, B05F241D

Recalling Firm/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact MsYogindra Dellow
201-847-5033
Manufacturer 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.
FDA Determined
Cause 2
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 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.
Quantity in Commerce 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..
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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