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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Smooth Interior Tubing

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  Class 2 Device Recall Disposable Smooth Interior Tubing see related information
Date Initiated by Firm August 10, 2018
Create Date October 16, 2018
Recall Status1 Terminated 3 on May 13, 2021
Recall Number Z-0120-2019
Recall Event ID 81076
Product Classification Tubing, pressure and accessories - Product Code BYX
Product Disposable Smooth Interior Tubing
Material: Polyethylene EVA copolymer.
This tubing is supplied non-sterile
P/N: 1024920 Rev. 01

Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.
Code Information Product Code: 243301 Lot Numbers: 572015 574717 578973 579100 582567
Recalling Firm/
Manufacturer		 A M Systems Inc
131 Business Park Loop
Box 850
Sequim WA 98382-8338
For Additional Information Contact Robert Thompson
360-683-8300 Ext. 1302
Manufacturer Reason
for Recall		 Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
FDA Determined
Cause 2		 Process control
Action On 08/10/2018, the firm, A-M Systems, sent an "URGENT: Notification of Product Recall/Correction" letter to customers via email informing them that it was determined that some of the Disposable Smooth Interior Tubing may pull apart when stretched. Customers were advised to provide the firm with the number of items distributed from the affected lots and the number of items still remaining in their inventory from these lots so that the firm could accurately track the status of this correction action. The customers are instructed to please use the enclosed form and self-addressed envelope to return the information to the firm immediately. Once the customers have provided the firm with an accurate count of items distributed and items remaining in the customer's control please destroy or discard any remaining product in your possession from these lot numbers. If you have any questions, please contact Quality Manager at Tel: 360.683.8300 x1302 or Email: rthompson@a-msystems.com.
Quantity in Commerce 610
Distribution US Distribution to states of: OH, PA, and NC.
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.
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