FDA Recalls URO Robotic Pack Surgical Kit Due to Sterilization Concerns
American Contract Systems Inc recalls 41 URO Robotic Pack surgical kits distributed in Ohio because sterilization assurance requirements could not be confirmed. Non-sterile equipment may lead to delayed treatment.
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: This is a Class II FDA recall involving sterile medical devices where sterilization assurance cannot be confirmed. The potential for non-sterile surgical equipment to cause treatment delays and loss of functionality represents a risk-of-harm scenario. No illnesses or injuries have been reported, which per the rubric limits this to High (3) severity.
Plain-English summary
American Contract Systems Inc has recalled 41 units of the URO ROBOTIC PACK, Model No LVUR44C (LVUR44C-03), distributed in Ohio. The recall affects the following lot numbers: 905241, 70-050739, 70-051020, 70-051480, 70-051606, and 70-051888.
The manufacturer was unable to confirm that product sterilization assurance requirements were met. This means the manufacturer cannot guarantee that the surgical kits are sterile, a critical requirement for medical devices used in surgical procedures.
The potential risks from non-sterile surgical equipment include loss or lack of functionality, which could lead to delayed treatment or prolonged medical procedures. No illnesses or injuries have been reported to date.
Patients or healthcare providers who have these units should contact American Contract Systems Inc to determine whether their specific lot number is affected and for guidance on next steps.
The recalled product
- Product
- URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
- Manufacturer
- American Contract Systems Inc
- Affected units
- 41
Distribution
Part of a larger recall action
This product is one of 32 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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