CLASS II Device recall · Reported 24 Oct 2018 · FDA Enforcement Report
Disposable Smooth Interior Tubing Material recalled by A M Systems
A M Systems is recalling Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer, distributed in North Carolina, Ohio, Pennsylvania. The recall was initiated on 10 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0120-2019
- FDA event ID
- 81076
- Recalling firm
- A M Systems, Sequim, WA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2018
- FDA classified
- 16 Oct 2018
- Reported
- 24 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 10 Aug 2018 | Recall initiated by company | |
| 16 Oct 2018 | Classified by FDA | +67 days |
| 24 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to states of: OH, PA, and NC.
Questions about this recall
Is Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer recalled?
Yes. A M Systems recalled Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer on 10 Aug 2018. The recall is Class II and its status is Terminated. Recall number Z-0120-2019.
Why was it recalled?
Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
Which lots are affected?
Product Code: 243301 Lot Numbers: 572015 574717 578973 579100 582567
Where was it sold?
US Distribution to states of: OH, PA, and NC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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