Reported Jun 19, 2013 · Terminated
VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood…
International Biomedical, Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: International Biomedical, Ltd. · 8508 Cross Park Dr · Austin, TX · 78754-4532
Is this the product you have?
- 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).
- Lot codes and dates
- Model/Part Number
209-2113or as part of kits 777-3103 and 777-3102
- Collection Bag Lot numbers
4389446544784516453044304489
- Model/Part Number
- Amount recalled
- 7,000
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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