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Class 2 Device Recall Introcan Safety IV Catheter |
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Date Initiated by Firm |
March 19, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on September 21, 2004 |
Recall Number |
Z-1092-04 |
Recall Event ID |
28912 |
510(K)Number |
K982805 K020785
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Product Classification |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
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Product |
Introcan 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 |
Recalling Firm/ Manufacturer |
Braun,B Medical Inc 901 Marcon Blvd Allentown PA 18109-9512
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For Additional Information Contact |
Art Morse, 610-266-0500 Ext. 2328
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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.
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FDA Determined Cause 2 |
Other |
Action |
The recalling firm received a product complaint of a mixed 18G Catheters with 22G Catheters. |
Quantity in Commerce |
86 units |
Distribution |
The 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 Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = FOZ and Original Applicant = B. BRAUN MEDICAL, INC.
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