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U.S. Department of Health and Human Services

Class 2 Device Recall Protex LineDraw Arterial Blood Sample

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  Class 2 Device Recall Protex LineDraw Arterial Blood Sample see related information
Date Initiated by Firm January 07, 2020
Date Posted April 15, 2020
Recall Status1 Terminated 3 on December 14, 2020
Recall Number Z-1715-2020
Recall Event ID 84681
510(K)Number K952516  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Code Information Portex LineDraw Arterial Blood Sampling Syringe: Item Number Lot Number 4042-2 3848838 4042-2 3848878 4042-2 3856950 4042-2 3859774 4042LH 3856958 4042LH 3859747
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact
603-352-3812
Manufacturer Reason
for Recall		 Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by letter on January 07, 2020. The "Urgent Medical Device Recall Notice", identified the removal of devices and instructed the customer to quarantine the affected products. The Notice provided the accompanying Recall Response Form to be completed and returned within 10 days of receipt to smithmedical4136@stericycle.com. The Notice details that the affected product must be returned to Stericycle for processing. The Notice instructed the distributor to notify their customers and to provide the customer a copy of the Recall Notice and Response Form. The Notice provided the contact email smithmedical4136@stericycle.com and phone number of 8669188738 for assistance.
Quantity in Commerce 720,100 total devices
Distribution USA: AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI,MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA. Int'l: CA, DE, AU.
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 = JKA and Original Applicant = SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
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