Surgical Positioning Device Recalled for Unconfirmed Sterilization Assurance
American Contract Systems Inc is recalling C-Section PPS positioning systems due to inability to confirm sterilization assurance requirements were met. The failure could lead to loss of functionality and 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: FDA Class II recall for sterilization assurance failure on a surgical medical device. While no illnesses or injuries have been reported, unconfirmed sterilization of surgical devices presents a significant risk of harm.
Plain-English summary
American Contract Systems Inc is recalling the C-SECTION PPS patient positioning system (Models LLCI66M, LLCI66M-02, LLCI66M-03, LLCI66M-04). The affected lots are: 907241, 70-050816, 70-051301, 70-051839, 70-052420, 70-052910, and 70-053100. A total of 1106 kits are affected, distributed nationwide.
The company is unable to confirm that product sterilization assurance requirements were met. This could result in loss or lack of functionality of the device, which may lead to delay or prolonged treatment during surgical procedures.
Customers who have received the affected product should check the lot number against the provided list. If the device matches an affected lot, contact American Contract Systems Inc for instructions on replacement or disposal.
The recalled product
- Product
- C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
- Manufacturer
- American Contract Systems Inc
- Affected units
- 1,106
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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