FDA Device recall Z-1531-2013
VIA Medical Collection Bag
- FDA Device
- Class II
- terminated
- Published 2013-06-19
On 2013-06-19 the FDA classified a Class II recall of VIA Medical Collection Bag by International Biomedical, citing international Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1531-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-24 |
| Published | 2013-06-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | International Biomedical |
| Distribution | US |
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).
Reason
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
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1531-2013%22
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