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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 Posted September 26, 2013
Recall Status1 Terminated 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
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9246684
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2276066
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3063436
3063440
3085498
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3123462
3123246
3184092






Catalog Number 405291
Lots
0154661
0174905
0252565
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1063738
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1124755
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2205106
2223162
2223337
2250088
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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
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GD885202
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GD888677
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B01F054D
B02F156D
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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 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.
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