Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer…

Date

Oct. 24, 2018

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

A M Systems Inc

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.

Reason

Some of the Disposable Smooth Interior Tubing may pull apart when stretched.

Distribution pattern

US Distribution to states of: OH, PA, and NC.

Quantity

610

Codes and lots

Product Code: 243301 Lot Numbers: 572015 574717 578973 579100 582567

Recall started

Aug. 10, 2018

Device type

Tubing, Pressure And Accessories

Root cause (FDA)

Process control

What the company told customers

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.

Recall number

Z-0120-2019

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0120-2019. The agency record governs; check it and the company before acting.