Bard Access Systems, Inc Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.
Brand
Bard Access Systems, Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Bard Access Systems, Inc is recalling Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic. due to Sterility of product is compromised by open seals in packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility of product is compromised by open seals in packaging.
Recommended Action
Per FDA guidance
Recall letters were sent to US customers on September 23, 2003. International customers were sent communication on September 24, 2003.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026