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U.S. Department of Health and Human Services

Class 2 Device Recall VIA Medical Collection Bag

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 Class 2 Recall
VIA Medical Collection Bag
see related information
Date Posted June 11, 2013
Recall Status1 Terminated on July 29, 2013
Recall Number Z-1531-2013
Recall Event ID 65341
Premarket Notification
510(K) Number
K922997 
Product Classification Pump, Infusion, Analytical Sampling - Product Code LZF
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).
Code Information 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
Recalling Firm/
Manufacturer
International Biomedical, Ltd.
8508 Cross Park Dr
Austin, Texas 78754-4532
Consumer Instructions Contact the recalling firm for information
Manufacturer 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
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LZF and Original Applicant = VIA MEDICAL CORP.
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