A M Systems Recalls Disposable Smooth Interior Tubing for Pulmonary Equipment
A M Systems Inc is recalling 610 units of Disposable Smooth Interior Tubing because the tubing may pull apart when stretched.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (pulling apart) that poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
A M Systems Inc is recalling 610 units of Disposable Smooth Interior Tubing, Product Number 1024920 Rev. 01. The tubing is made of Polyethylene EVA copolymer and is supplied non-sterile. It is a disposable pulmonary equipment interconnect used in ventilation and anesthesia machines.
The recall was initiated because some of the tubing may pull apart when stretched. The affected product was distributed in the United States to the states of Ohio, Pennsylvania, and North Carolina. The specific lot numbers involved are 572015, 574717, 578973, 579100, and 582567.
Healthcare facilities and consumers should stop using the affected tubing immediately. Users should check their inventory for the specific product number and lot numbers listed above. If the product is found, it should be removed from service and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- 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.
- Manufacturer
- A M Systems Inc
- Affected units
- 610
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code: 243301 Lot Numbers: 572015 574717 578973 579100 582567
Distribution
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