FDA Medical Device Recalls (openFDA)
Bard Access Systems, Inc: Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.
- Recall number
- Z-0098-04
- Recalling firm
- Bard Access Systems, Inc
- Product
- Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.
- Status
- Terminated
- Initiated
- 2003-09-23
- Posted
- 2003-11-06
- Terminated
- 2004-03-18
- Reason
- Sterility of product is compromised by open seals in packaging.
- 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
- 106,500 units
- Distribution
- Nationwide. Foreign distribution to Australia, Brazil, Canada, China, Hong Kong, India, Japan, Malaysia, Singapore, Taiwan, Venezuela.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K863606"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 3006260740
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28