Recall Z-1531-2013 ยท LZF Pump, Infusion, Analytical Sampling
International Biomedical, Ltd.
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).
| Date | Jun 11, 2013 (initiated May 24, 2013) |
| 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 |
| Root cause | Device Design |
| Action | International Biomedical decided to recall and sent "Product Bulletin" notification letters to their consignees on 05/24/2013 or 05/30/2013. The letter described the product issue and provided customers with recommended actions. Questions were directed to (512) 873-0033. |
| Quantity | 7,000 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922997 | VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. Via Medical Corp., Jan 11, 1994 |