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U.S. Department of Health and Human Services

Class 2 Device Recall Argyle" Suction Tubing

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 Class 2 Device Recall Argyle" Suction Tubingsee related information
Date Initiated by FirmOctober 24, 2017
Date PostedMarch 05, 2018
Recall Status1 Terminated 3 on October 26, 2020
Recall NumberZ-0936-2018
Recall Event ID 79352
Product Classification Tubing, noninvasive - Product Code GAZ
ProductArgyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension for different types of devices in an operating room, bonded with 2 female sure grip connectors at each end of the tube to facilitate the plug/ insertion of the device and also includes a male connector that can be used for devices designed with female connectors, This product is sterile, non-conductive and latex free.
Code Information 710016864X
Recalling Firm/
Manufacturer		 Medtronic Minimally Invasive Therapies Group
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact
508-261-8000
Manufacturer Reason
for Recall		Incorrect packaging. In one lot of Argyle Suction Tubing, the pouch may be incorrectly labeled as the Salem Sump Dual Lumen Stomach Tube. This product may have been distributed within the case of Argyle Suction Tubing.
FDA Determined
Cause 2		Packaging process control
ActionAn URGENT MEDICAL DEVICE RECALL letter was issued to customers on October 24, 2017. This letter notified customers of the products subject to the recall and stated the following: The primary package labeling (Label closest to the product) may be incorrect. Customers can identify the affected product by consulting Attachment B. Please quarantine and return any unused products of the item codes and lot detailed above. Unused products from the affected item code and lots should be returned as described in the Required Actions section below. If you have distributed the Argyle" Suction tubing listed above, please promptly forward the information from this letter to those recipients. All unused products from the affected item codes and lots must be returned. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in Commerce58,954
DistributionUSA (nationwide) Distribution
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.
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