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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Kits for Epidural Anesthesia Administration

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  Class 2 Device Recall Integra Kits for Epidural Anesthesia Administration see related information
Date Initiated by Firm October 28, 2013
Date Posted December 17, 2013
Recall Status1 Terminated 3 on January 29, 2014
Recall Number Z-0533-2014
Recall Event ID 66885
510(K)Number K945484  
Product Classification Anesthesia conduction kit - Product Code CAZ
Product Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only

Product Usage:
The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.
Code Information Kit Cat No: 10-2433,13-2595,13-2616,13-2628,3104195,3403061,3403150,3403316,3403579,3403727,3403776,3403813,3403989,3404131,3404269,3404293,3404417,3404468,3404578,3503559,CUS025,CUS1121-01,CUS1164-02,CUS1202-04,CUS1298-03,CUS1376,CUS1376,CUS1400-01,CUS1406-03,CUS1415-04,CUS1568-01,CUS1664-01,CUS1696,CUS1723,CUS1760,CUS1773-01,CUS1797,CUS279-02,CUS416,CUS597,CUS628-02,CUS755,PISLL7,RSM394,RSM395,SS1246,SS2036-01,
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp. d.b.a. Integra Pain Management
3498 West 2400 South #1050
Salt Lake City UT 84119
For Additional Information Contact Mr. David E. Gronostajski
609-936-6822
Manufacturer Reason
for Recall		 Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.
FDA Determined
Cause 2		 Component design/selection
Action BD Medical sent a Product Advisory Notice letter dated August 23, 2013 to Iaffected consignees by via traceable courier. The letter identified the affected product, problem and actions to be taken. Distributor have been asked to forward copies of the notification to their customers. For questions call BD Customer Service at 1-888-237-2762.
Quantity in Commerce 359,250
Distribution USA Nationwide Distribution and one foreign consignee in Mursalat.
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.
510(K) Database 510(K)s with Product Code = CAZ and Original Applicant = PROFESSIONAL MEDICAL DEVICE CONSULTANTS
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