International Biomedical Recalls VIA Medical Collection Bags Due to Connector Issues
International Biomedical is recalling VIA Medical Collection Bags because the connector can become occluded if the luer lock is over-tightened.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard involves potential occlusion of the connector, which is a functional defect rather than a direct injury or contamination risk, fitting the Moderate severity criteria for low-risk mechanical issues.
Plain-English summary
International Biomedical, Ltd. is recalling approximately 7,000 VIA Medical Collection Bags. These bags are accessory waste bags used with the sterile LVM blood gas sensor and LVM Monitor. The affected products are packaged in tyvek pouches and are included in replacement kit 777-3103 or LVM sensor kit 777-3102. The collection bags have model/part number 209-2113 and specific lot numbers: 4389, 4465, 4478, 4516, 4530, 4430, and 4489.
The recall was initiated after the company received reports of interference between the collection bag and the extension set connectors. Evaluation of the components indicated that the collection bag connector can become occluded due to the over-tightening of the luer lock by the end user. To address this issue, the connector design on the collection bag has been improved.
The affected products were distributed nationwide. Users should check their inventory for the specific model and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or a designated distributor for replacement or refund, in accordance with the recall instructions provided by International Biomedical.
The recalled product
- 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
- Manufacturer
- International Biomedical, Ltd.
- Category
- Medical Device — Accessories
- Affected units
- 7,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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
Distribution
Distributed nationwide across the United States.
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