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U.S. Department of Health and Human Services

Class 2 Device Recall Winged Infusion Sets

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  Class 2 Device Recall Winged Infusion Sets see related information
Date Initiated by Firm September 23, 2003
Date Posted November 06, 2003
Recall Status1 Terminated 3 on March 18, 2004
Recall Number Z-0098-04
Recall Event ID 27431
510(K)Number K863606  
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
Product Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.
Code Information Product Code 0603300 Gauge size 20 needle length 1.5'' Lot # 22FN4059; Product Code 0604190 Gauge Size 20 Needle Length 0.75'' Lot # 22FN4062; Product Code 0604200 Gauge Size 20 Needle Length 1.0'' Lot # 22KM1206, # 22KM1209, # 22KM1220; Product Code 0604210 Gauge Size 22 Needle Length 0.75'' Lot # 22KM1207; Product Code 0604220 Gauge Size 22 Needle Length 1.0'' Lot # 22KM1210; Product Code 0604270 Gauge Size 20 needle Length 0.5'' Lot # 22KM1211; Product Code 2205220 Gauge Size 20 Needle Length 0.75''  Lot # 22KM1213, # 22KM1214, # 22KM1215,   # 22KM1216, # 22KM1217, #22KM1222,   # 22KM1223, # 22KM1224, # 22KMX222,   # 22KMX223, # 22KMX224, # 22FN4057;  Product Code 2205222, Gauge Size 22 Needle Length 0.75'', Lot # 22FN4056;  Product Code 2206219 Gauge Size 19 Needle Length 1.0'', Lot # 22KM1218, # 22KM1219; Product Code 2206220, Gauge size 19 Needle Length 1.0'', Lot # 22KM1225, # 22KM1219. 
Recalling Firm/
Manufacturer		 Bard Access Systems, Inc
5425 W Amelia Earhart Dr
Salt Lake City UT 84116
For Additional Information Contact Peggy Keiffer
801-595-4903
Manufacturer Reason
for Recall		 Sterility of product is compromised by open seals in packaging.
FDA Determined
Cause 2		 Other
Action Recall letters were sent to US customers on September 23, 2003. International customers were sent communication on September 24, 2003.
Quantity in Commerce 106,500 units
Distribution Nationwide. Foreign distribution to Australia, Brazil, Canada, China, Hong Kong, India, Japan, Malaysia, Singapore, Taiwan, Venezuela.
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 = FMI and Original Applicant = CORMED, INC., SUB. C.R.BARD, INC.
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