Allen Medical Systems Recalls Arthex S3 Arm Sleeve Connectors
Allen Medical Systems is recalling 420 Arthex S3 Arm Sleeve Connectors because they may separate unexpectedly during use, potentially causing moderate injury to patients.
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 is classified as FDA Class II and involves a risk of moderate injury to patients due to unexpected device separation, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Allen Medical Systems, Inc. is recalling 420 units of the Arthex S3 Arm Sleeve Connector, Catalog Number AR-1650-02. These devices were manufactured and distributed between March and November 2016. The recall is limited to units distributed in the state of Florida.
The recall is being issued because the unit could separate unexpectedly during use. This failure would allow the patient's arm to fall out of suspension during a procedure, possibly causing moderate injury to the patient. The source text notes that this potential defect is not apparent to the user.
Healthcare facilities and users should check their inventory for the affected catalog number and lot codes listed in the official recall notice. If the device is found, it should be removed from service and returned to the manufacturer or disposed of according to the instructions provided by Allen Medical Systems.
The recalled product
- Product
- Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
- Manufacturer
- Allen Medical Systems, Inc.
- Affected units
- 420
Distribution
Distributed in 1 state:
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