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U.S. Department of Health and Human Services

Class 2 Device Recall Introcan Safety IV Catheter

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 Class 2 Device Recall Introcan Safety IV Cathetersee related information
Date Initiated by FirmMarch 19, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on September 21, 2004
Recall NumberZ-1092-04
Recall Event ID 28912
510(K)NumberK020785 K982805 
Product Classification Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
ProductIntrocan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: Catalog Number 4253540 - Lot number 3G26258U02 Catalog Number 4253540 - Lot number 3G27258U02
Code Information Catalog Number is 4253540 and the lot numbers are 3G26258U02 and 3G27258U02
FEI Number 2523676
Recalling Firm/
Manufacturer		 Braun,B Medical Inc
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information ContactArt Morse,
610-266-0500 Ext. 2328
Manufacturer Reason
for Recall		Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number.
FDA Determined
Cause 2		Other
ActionThe recalling firm received a product complaint of a mixed 18G Catheters with 22G Catheters.
Quantity in Commerce86 units
DistributionThe affected recalling units were distributed nationwide to the following states: AZ, CA, GA, IL, IN, MD, OH, OK, OR, MA, MI, NC, NJ, NY, OR, PA, TX, UT, VA, WI
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 = FOZ
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