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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 Device Recall VIA Medical Collection Bagsee related information
Date Initiated by FirmMay 24, 2013
Date PostedJune 11, 2013
Recall Status1 Terminated 3 on July 29, 2013
Recall NumberZ-1531-2013
Recall Event ID 65341
510(K)NumberK922997 
Product Classification pump, infusion, analytical sampling - Product Code LZF
ProductVIA 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 TX 78754-4532
For Additional Information Contact
512-873-0033
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		Device Design
ActionInternational 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 Commerce7,000
DistributionNationwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LZF
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