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U.S. Department of Health and Human Services

Class 2 Device Recall smiths medical portex Loss of Resistance Device

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  Class 2 Device Recall smiths medical portex Loss of Resistance Device see related information
Date Initiated by Firm December 08, 2020
Create Date October 19, 2021
Recall Status1 Terminated 3 on August 04, 2023
Recall Number Z-0152-2022
Recall Event ID 88741
510(K)Number K172410  
Product Classification Needle, conduction, anesthetic (w/wo introducer) - Product Code BSP
Product smiths medical portex Loss of Resistance Device, REF 100/398/000
Code Information Lot Numbers: 3980977, 3986734, 3994302, 3994303 and 4001003
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Dave Halverson
763-383-3310
Manufacturer Reason
for Recall		 The labeling was missing information on sterilization and prohibition of reuse.
FDA Determined
Cause 2		 Error in labeling
Action The firm notified their consignees of the recall by email on 12/08/2021. Distributors were directed to notify their consignees. The firm is seeking return of the product.
Quantity in Commerce 3420 devices
Distribution Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France, Switzerland, Israel, Germany, Sweden, Italy, New Zealand, Australia, South Africa, Netherlands, Slovenia, United Arab Emirates
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 = BSP and Original Applicant = Smiths Medical ASD, Inc.
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