Devices

Device Recall Site Rite Systems containing needle guide kits.

Model / Serial
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.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
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.
Product Description
Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each.
Manufacturer
Bard Access Systems, Inc
1 Event
- Recall of Device Recall Site Rite Systems containing needle guide kits.

Manufacturer

Bard Access Systems, Inc

Manufacturer Address
Bard Access Systems, Inc, 5425 Amelia Earhart Dr, Salt Lake City UT 84116-3713
Source
USFDA

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