Lumbar Spine Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems Inc is recalling 106 SPINE LUMBAR PACK kits (Models UTSL72AA, UTSL72AB) because the manufacturer cannot confirm sterilization assurance requirements were met, potentially causing functionality loss and treatment delays.
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 involving a sterilization assurance failure on a medical device. No illnesses or injuries have been reported, but sterilization failure presents a risk-of-harm scenario with potential for infection and treatment delays, meeting the criteria for a risk-of-harm product.
Plain-English summary
American Contract Systems Inc is recalling 106 SPINE LUMBAR PACK kits, Models UTSL72AA and UTSL72AB (UDI-DI 00191072179753, Lots 939241, 88241, 70-052063, 70-052618A, 70-053157). The manufacturer is unable to confirm that sterilization assurance requirements were met.
Spine lumbar packs are medical devices used in spinal treatment and procedures. Without confirmed sterilization assurance, the product may lose functionality, which could lead to delay or prolonged treatment for patients.
The recalled kits were distributed in Ohio.
The recalled product
- Product
- SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
- Manufacturer
- American Contract Systems Inc
- Affected units
- 106
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 00191072179753 Lots 939241 88241 70-052063 70-052618A 70-053157
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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