American Contract Systems Spine Pack kits recalled for insufficient sterilization aeration
American Contract Systems is recalling Spine Pack convenience kits (Lot 980241) due to incomplete post-sterilization aeration. The affected kits were distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
What this means for you
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 an FDA Class II medical device recall involving a sterilization process defect. No illnesses or injuries have been reported, but incomplete aeration following sterilization on spine surgical kits represents a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.
Plain-English summary
American Contract Systems, Inc. is recalling Spine Pack convenience kits due to a sterilization process defect. The kits were released with insufficient post-sterilization aeration time, meaning they may contain residual sterilization gases.
The recalled product is the American Contract Systems Spine Pack convenience kit in Lot 980241 (UDI-DI 00191072202499, expiration date 1/10/2025). Distribution was limited to California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.
The recalled product
- Product
- American Contract Systems Spine Pack convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- aeration-failure
- residual-sterilant
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 (3)
- UDI-DI 00191072202499
- Lot 980241
- Exp. Date 1/10/2025.
Distribution
Distributed nationwide across the United States.
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