Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.
- Company
- Bard Access Systems, Inc.
- Recall Initiated
- September 23, 2003
- Posted
- November 6, 2003
- Terminated
- March 18, 2004
- Recall Number
- Z-0098-04
- Quantity
- 106,500 units
- Firm Location
- Salt Lake City, UT
Reason for Recall
Sterility of product is compromised by open seals in packaging.
Distribution
Nationwide. Foreign distribution to Australia, Brazil, Canada, China, Hong Kong, India, Japan, Malaysia, Singapore, Taiwan, Venezuela.
Lot / Code Info
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.
Root Cause
Other
Action Taken
Recall letters were sent to US customers on September 23, 2003. International customers were sent communication on September 24, 2003.