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U.S. Department of Health and Human Services

Class 2 Device Recall Peripherally inserted central catheter.

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 Class 2 Device Recall Peripherally inserted central catheter.see related information
Date Initiated by FirmMarch 25, 2005
Date PostedDecember 15, 2005
Recall Status1 Terminated 3 on August 08, 2011
Recall NumberZ-0286-06
Recall Event ID 31670
510(K)NumberK920755 
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product16 G / 5F Dual Lumen L-Cath Complete Kit with Introsyte
Code Information REF 384427
Recalling Firm/
Manufacturer
Becton Dickinson Medical Systems
9450 S State St
Sandy UT 84070-3213
For Additional Information Contact
801-565-2341
Manufacturer Reason
for Recall
Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
FDA Determined
Cause 2
Other
ActionConsignees were notified via telephone and fax letter, beginning 04/25/2005.
Quantity in Commerce3750 units
DistributionAL, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NJ, OH, OK, PA, TN, TX, WA. No Government or military consignees. Foreign distribution to Australia, Canada, Japan.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LJS
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