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).
Enforcement
- Recall Number
- Z-1531-2013
- Event ID
- 65341
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- International Biomedical, Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 19, 2013
- Initiation Date
- May 24, 2013
- Classification Date
- June 11, 2013
- Termination Date
- July 29, 2013
- Address
- 8508 Cross Park Dr, N/A, Austin, TX, 78754-4532, United States
Description
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 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
Model/Part Number: 209-2113, or as part of kits 777-3103 and 777-3102. Collection Bag Lot numbers: 4389, 4465, 4478, 4516, 4530, 4430, 4489
Nationwide Distribution.
7,000