Recall Z-1531-2013— International Biomedical, Ltd.

Name: FDA recall Z-1531-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-24

Class II · Terminated

Class II FDA medical device recall by International Biomedical, Ltd., initiated 2013-05-24, terminated 2013-07-29. It names one FDA 510(k) clearance: K922997. 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).. 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.

Recalling firm: International Biomedical, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2013-05-24
Terminated: 2013-07-29
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K922997 — VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.Via Medical Corp.·cleared 1994-01-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.