Home / Recalls / Medical Devices
International Biomedical, Ltd. recalls VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood
Recalled June 19, 2013 · FDA recall Z-1531-2013 · International Biomedical
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 · FDA Class II
Units
7,000
Sold at
Nationwide Distribution.
Description
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
Product
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).
Manufacturer(s)
International Biomedical, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →