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U.S. Department of Health and Human Services

Class 2 Device Recall VersaSafe Plastic Cannula

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  Class 2 Device Recall VersaSafe Plastic Cannula see related information
Date Initiated by Firm June 30, 2017
Create Date August 11, 2017
Recall Status1 Terminated 3 on February 03, 2021
Recall Number Z-3030-2017
Recall Event ID 77696
510(K)Number K945070  
Product Classification Set, administration, intravascular - Product Code FPA
Product VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200

Product Usage:
Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.
Code Information Lot No. 1470303001, 1570314802, 1470303002, 1570317701, 1470304601, 1570317702, 1470306602, 1570317703, 1470306301, 1570317704, 1470306602, 1570322001, 1470311301, 1660771501, 1470306301, 1470311302, 1470314801
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
Manufacturer Reason
for Recall		 Punctures in blister packaging that was detected during the packaging process.
FDA Determined
Cause 2		 Packaging process control
Action BD sent an Urgent Medical Device Recall letter dated June 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use and return the affected lot to CareFusion for replacement. For recall related questions contact BD Support Center 1-888-562-6018.
Quantity in Commerce 1,546,800 units
Distribution Worldwide Distribution in the states of : CO, IL, IN, MD, MI, NY, OH, & TX. and foreign countries of: Australia, New Zealand, & Japan.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FPA and Original Applicant = IMED CORP.
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