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U.S. Department of Health and Human Services

Class 2 Device Recall Catheter

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 Class 2 Device Recall Cathetersee related information
Date Initiated by FirmNovember 26, 2018
Create DateNovember 08, 2019
Recall Status1 Terminated 3 on May 13, 2021
Recall NumberZ-0352-2020
Recall Event ID 81708
510(K)NumberK990236 
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
ProductProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
Code Information Model number 306701;   Lot numbers: 3635765, 3639446, 3642834, 3646828, 3646829, 3646830, 3646831, 3646832, 3646833, 3651082.
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactDave Halverson
763-383-3072
Manufacturer Reason
for Recall		Certain lots of the Model 306701 ProtectIV Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.
FDA Determined
Cause 2		Equipment maintenance
ActionOn about November 26, 2018, Smiths Medical sent an URGENT MEDICAL DEVICE RECALL NOTICE via email or FedEx, (where email addresses are not available) and accompanying Recall Response Forms to all consignees who purchased potentially affected product. Consignees with potentially affected product were instructed to immediately segregate the product and return them to Stericycle, via pre-paid shipping label. They we also instructed to notify customers if the affected product was further distributed and complete and return the Recall Response Form. Questions can be submitted to Smith Medical via email at fieldactions@smiths-medical.com.
Quantity in Commerce219,150 devices
DistributionUnited States - AK, AZ, FL, GA, IL, IN, KS, LA, MD, MN, MS, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. One foeign consignee in Costa Rica
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 = FOZ
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