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.
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 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.
- Affected units
- 3
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
Part of a larger recall action
This product is one of 8 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.
See all 8 products in this recall →Related recalls
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