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U.S. Department of Health and Human Services

Class 2 Device Recall Portex

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  Class 2 Device Recall Portex see related information
Date Initiated by Firm February 28, 2020
Create Date April 29, 2020
Recall Status1 Terminated 3 on September 01, 2021
Recall Number Z-1820-2020
Recall Event ID 85375
510(K)Number K172410  
Product Classification Anesthesia conduction kit - Product Code CAZ
Product Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid pressure and/or collect cerebrospinal fluid specimens. Key components include skin prep materials, lancet-point needle, manometer with stopcock and extension set, and specimen vials.
Code Information Lot #3842192, Model no. 4826PL-20.
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact
763-383-3072
Manufacturer Reason
for Recall		 Cases of Portex¿ Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20.
FDA Determined
Cause 2		 Labeling mix-ups
Action Smiths Medical notified customers on 03/21/2020 via "urgent Medical Device Recall" letter. The letter identified the affected product and instructed to customers to quarantine and return the affected product. The firm also instructed the customers to notify their customers if the affected product was further distributed.
Quantity in Commerce 100 units.
Distribution US Nationwide distribution in the states of MA, MD, MO and IN.
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 = CAZ and Original Applicant = Smiths Medical ASD, Inc.
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