FDA-Device2013-06-19Class II

VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102).

International Biomedical, Ltd.
Hazard

International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. To alleviate the occurrence of this issue in the fixture, the connector on the collection bag has been improved to

Sold states
Nationwide Distribution.
Affected count
7,000
Manufactured in
8508 Cross Park Dr, N/A, Austin, TX, United States
Products
VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood gas sensor with the LVM Monitor. The collection bag is packaged in a tyvek pouch which is included in either replacement kit (777-3103) or LVM sensor kit (777-3102).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1531-2013

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