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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmOctober 23, 2017
Create DateMarch 17, 2018
Recall Status1 Terminated 3 on June 21, 2018
Recall NumberZ-1091-2018
Recall Event ID 79329
Product Classification Tray, surgical - Product Code LRP
ProductLATEX FREE IV START SET
Code Information IV4885 IV5600  Lot codes: 2015090790 2015112390 2016012590 2016030790 2016052390 2016062790 2016080890 2017010290 2017013090 2017031390 2017052290 2015110201 2016010401 2016040401 2016061301 2016071101 2016082201 2017021601 2017041790 2017052290 2016122701 2015092801 2016022201 2017031301 2017062690 
FEI Number 3008403546
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
Manufacturer Reason
for Recall		Convenience Kit containing components to assist practitioner with IV placement and securement.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn October 16, 2017 a PRODUCT CORRECTION letter was issued to customers notifying them that if they had any kits in their inventory, Centurion will supply labels to affix to the front of each kit instructing the user to discard the prep pad upon opening the kit. Other components of the kit may continue to be used and are NOT within the scope of this recall.
DistributionNationally
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.
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