Z-0098-04

Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic

Name: Z-0098-04 Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic
Creator: Bard Access Systems, Inc
Published: 2003-09-23
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2003-09-23 / Terminated / root cause: packaging

FDA source

Bard Access Systems, Inc began a recall of Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic on 2003-09-23. The reason FDA records is "Sterility of product is compromised by open seals in packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0098-04
Status: Terminated
Initiated: 2003-09-23
Posted: 2003-11-06
Terminated: 2004-03-18
Recalling firm: Bard Access Systems, Inc.
Product: Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.
Product code: FMI Needle, Hypodermic, Single Lumen
Reason for recall: Sterility of product is compromised by open seals in packaging.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: 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.

Product code FMI

K863606Class IIButterfly Non-Coring Needle SetCormed, Inc., Sub. C.R.Bard, Inc. / cleared 1986-12-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)