Z-1531-2013Class II

VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile...

Name: Z-1531-2013 VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile...
Creator: International Biomedical, Ltd.
Published: 2013-05-24
License: https://open.fda.gov/license/

International Biomedical, Ltd. / initiated 2013-05-24 / Terminated / root cause: design

FDA source

International Biomedical, Ltd. began a recall of 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... on 2013-05-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1531-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-24
Posted: 2013-06-11
Terminated: 2013-07-29
Recalling firm: International Biomedical, Ltd.
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).
Product code: LZF Pump, Infusion, Analytical Sampling
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
Root cause tag: design
FDA 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 in commerce: 7,000
Distribution: Nationwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1531-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1531-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-11

Product code LZF

K922997Class IIVia 1-01 Infusion Pump/blood Chem. Syst. -- Mod.Via Medical Corp. / cleared 1994-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)