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U.S. Department of Health and Human Services

Class 2 Device Recall ProVent Arterial Blood Sampling Kit

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  Class 2 Device Recall ProVent Arterial Blood Sampling Kit see related information
Date Initiated by Firm September 06, 2023
Date Posted October 20, 2023
Recall Status1 Open3, Classified
Recall Number Z-0141-2024
Recall Event ID 93094
510(K)Number K952516  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
Code Information UDI/DI 30351688028635, Lot Number 4331283
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Customer Service
763-258-5367
Manufacturer Reason
for Recall		 The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and Lot# 4331283. Tubes without caps have the potential to generate delayed or erroneous test results and/or exposure to infectious blood.
FDA Determined
Cause 2		 Process control
Action Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/06/2023 by mail. The notice explained the problem with the device, potential risk, and requested the following: 1. Discontinue use, distribution, and quarantine all affected product in inventory. 2. Notify all potential users within the consignee organization 3. Distributors were directed to notify their customers. Questions: Customer Service 1-(800)-258-5361
Quantity in Commerce 31900 devices
Distribution US
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
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