Class II — International Biomedical, Ltd.
| Recalling firm | INTERNATIONAL BIOMEDICAL, LTD. |
|---|---|
| Registered facility | INTERNATIONAL BIOMEDICAL, LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| 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). |
| Quantity | 7,000 |
| Distribution | Nationwide Distribution. |
| Initiated | 2013-05-24 |
| Classified | 2013-06-11 |
| Terminated | 2013-07-29 |
| Recall number | Z-1531-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — International Biomedical, Ltd. (Z-1531-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65341/
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