VIA Medical Collection Bag — Class II medical device recall Z-1531-2013
Terminated recall by International Biomedical, Ltd., reported 2013-06-19, distributed nationwide. International Biomedical has received reports of interference between the collection bag and the extension set
| Recall number | Z-1531-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Biomedical, Ltd., Austin, TX, United States |
| Recall initiated | 2013-05-24 |
| Classified | 2013-06-11 |
| Reported by FDA | 2013-06-19 |
| Terminated | 2013-07-29 |
| Distributed | Nationwide (US) |
| Quantity | 7,000 |
| Lot numbers | 4389, 4430, 4465, 4478, 4489, 4516, 4530 |
| Model numbers | 209-2113 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1531-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.