VIA Medical Collection Bag recall
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).
Why was VIA Medical Collection Bag recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- 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).
- Recalling firm
- International Biomedical, Ltd.
- Quantity
- 7,000
- Distribution
- Nationwide Distribution.
- Recall date
- June 19, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)