Z-0120-2019Class II

Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile...

Name: Z-0120-2019 Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile...
Creator: A M Systems Inc
Published: 2018-08-10
License: https://open.fda.gov/license/

A-M Systems / initiated 2018-08-10 / Terminated / root cause: manufacturing process

FDA source

A M Systems Inc began a recall of Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth... on 2018-08-10. FDA classified it as Class II and gives the reason as "Some of the Disposable Smooth Interior Tubing may pull apart when stretched". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0120-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-10
Posted: 2018-10-16
Terminated: 2021-05-13
Recalling firm: A-M Systems
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.
Product code: BYX Tubing, Pressure And Accessories
Reason for recall: Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
Root cause tag: manufacturing process
FDA root cause: 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: [email protected].
Quantity in commerce: 610
Distribution: US Distribution to states of: OH, PA, and NC.
Product codes and lots: Product Code: 243301 Lot Numbers: 572015 574717 578973 579100 582567

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0120-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0120-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-24	2018-10-16

Product code BYX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)