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
- Recall Number
- Z-0120-2019
- Event Number
- 81076
- Firm
- A M Systems Inc
- FEI Number
- 3020614
- Product Code
- BYX
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- August 10, 2018
- Terminated
- May 13, 2021
- Address
- 131 Business Park Loop Box 850, Sequim, WA, 98382-8338
Description
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.
Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
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].
US Distribution to states of: OH, PA, and NC.
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