| Class 2 Device Recall smiths medical portex Loss of Resistance Device |  |
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
|
|
|
|