Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each.
This recall has been terminated (originally issued April 22, 2005).
- Company
- Bard Access Systems, Inc.
- Recall Initiated
- November 3, 2004
- Posted
- April 22, 2005
- Terminated
- April 22, 2005
- Recall Number
- Z-0720-05
- Quantity
- 2360 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Conductivity gel pouches, labeled as sterile, may not be sterile.
Distribution
Nationwide. Foreign distribution to: Austria; Bahrain, Belgium, Bermuda, Brazil, Canada, Greece, Hong Kong, Italy, Japan, Kuwait, Malaysia, Mexico, Norway, Oman, Pakistan, Portugal, Qatar, Saudi Arabia, Switzerland, Turkey, United Arab Emirates, United Kingdom.
Lot / Code Info
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.
Root Cause
Other
Action Taken
All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04.