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U.S. Department of Health and Human Services

Class 2 Device Recall Portex ProVent Arterial Blood Sample

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 Class 2 Device Recall Portex ProVent Arterial Blood Samplesee related information
Date Initiated by FirmJanuary 07, 2020
Date PostedApril 15, 2020
Recall Status1 Terminated 3 on December 14, 2020
Recall NumberZ-1716-2020
Recall Event ID 84681
510(K)NumberK952516 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductPortex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Code Information Portex Pro-Vent Arterial Blood Sampling Kit: Item Number Lot Number G1724 3859779 G1702 3863522 4599P-1 3859751 4599P-1 3862142 4599P-1 3863544 4599P-1 3863545 4599P-1 3869581 G1665 3856947 4588P-2 3862145 4558PE 3859727
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		Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.
FDA Determined
Cause 2		Process control
ActionThe 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 Commerce127,700 total devices
DistributionUSA: 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 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 = JKA
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