Bard Access Systems, Inc Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each.
Brand
Bard Access Systems, Inc
Lot Codes / Batch Numbers
Site Rite II System - Item Numbers: 9740001-9740006. Serial number ranges: 32563-32624, 33450-33549, 35900-35999, 37300-37399, 34900-35149, 36100-36199, 36450-36510, A02001-A02383. Site Rite IV System - Item Numbers: 9740050-9740052, 9740059, 9740091, 9760004, 9760018. Serial number ranges: B03001-B03588, B03590-B03601, B03603-B03607, B03609, B03632, B03636, B03647.
Products Sold
Site Rite II System - Item Numbers: 9740001-9740006. Serial number ranges: 32563-32624, 33450-33549, 35900-35999, 37300-37399, 37950-38028. Site Rite 3 System - Item Numbers: 9740010-9740019. Serial number ranges: 32774-32974, 34900-35149, 36100-36199, 36450-36510, A02001-A02383. Site Rite IV System - Item Numbers: 9740050-9740052, 9740059, 9740091, 9760004, 9760018. Serial number ranges: B03001-B03588, B03590-B03601, B03603-B03607, B03609, B03632, B03636, B03647.
Bard Access Systems, Inc is recalling Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each. due to Conductivity gel pouches, labeled as sterile, may not be sterile.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Conductivity gel pouches, labeled as sterile, may not be sterile.
Recommended Action
Per FDA guidance
All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04.
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