FDA Medical Device Recalls (openFDA)
A M Systems Inc: 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.
- Recall number
- Z-0120-2019
- Recalling firm
- 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.
- Status
- Terminated
- Initiated
- 2018-08-10
- Posted
- not on file
- Terminated
- 2021-05-13
- Reason
- Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
- 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: rthompson@a-msystems.com.
- Quantity
- 610
- Distribution
- US Distribution to states of: OH, PA, and NC.
- Lot, serial or model codes
- Product Code: 243301 Lot Numbers: 572015 574717 578973 579100 582567
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BYX
- Firm FEI
- 3020614
- Firm city
- Sequim
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28