Open Heart Surgery Kit Sterilization Assurance Cannot Be Confirmed
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient 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 medical device recall with sterilization assurance failure. Potential loss of functionality in surgical instruments is a risk-of-harm hazard. No illnesses or injuries are reported in the source.
Plain-English summary
American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits (Model Nos LLOH01I-01 and LLOH01I). The manufacturer cannot confirm that sterilization assurance requirements were met for these devices.
Unsterilized or improperly sterilized surgical instruments could lose functionality during use, potentially causing delays or prolonged treatment during open heart surgical procedures.
Healthcare facilities using these kits should immediately discontinue use of products with lot numbers 898241, 70-050704, or 70-051731. Contact American Contract Systems Inc for instructions on return or replacement of affected devices.
The recalled product
- Product
- OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
- Manufacturer
- American Contract Systems Inc
- Affected units
- 90
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)
- UDI-DI 00191072219251 Lots 898241 70-050704 70-051731
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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