Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each.
FDA device recall Z-0720-05 · posted 2005-04-22 · Terminated
Recall details
- Recalling firm
- Bard Access Systems, Inc
- Reason for recall
- Conductivity gel pouches, labeled as sterile, may not be sterile.
- Action taken
- All domestic consignees were notified by letter on 10/04/2004. All foreign consignees were notified by letter on 10/15/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 2360 units
- 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 Arabi
- Date initiated
- 2004-11-03
- Date posted
- 2005-04-22
- Date terminated
- 2005-04-22
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.