J T Posey Recalls Biothane Restraint Cuffs Due to Tensile Strength Defect
J T Posey Company is voluntarily recalling 1,673 Biothane Restraint Cuffs because they failed to meet tensile strength specifications, posing a risk of disconnection.
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 (tensile strength) that could lead to patient harm or loss of protection, but no injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
J T Posey Company is voluntarily recalling Posey Biothane Restraint Cuffs, Catalog Number 2900. The recall involves 1,673 units that were distributed nationwide. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.
The recall was initiated because the cuffs did not meet the required specifications for tensile strength. A failure of the rivets could allow the cuff to become disconnected from the connecting strap, which would allow patients to regain free use of the limb.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.
- Manufacturer
- J T Posey Company
- Category
- Medical Device — Restraints
- Affected units
- 1,673
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)
- The model/catalog number for the device is 2900. All lots are being recalled.
Distribution
Distributed nationwide across the United States.
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