Medical Device Sterilization Assurance Recall: MAJOR DIEP Surgical Kits
American Contract Systems Inc is recalling 17 MAJOR DIEP surgical kits because sterilization assurance requirements cannot be confirmed. This creates a risk of device malfunction and treatment delays.
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: Class II medical device recall involving unconfirmed sterilization assurance. This creates a theoretical risk of harm without reported illnesses or injuries, meeting the rubric criterion for High severity.
Plain-English summary
American Contract Systems Inc is recalling 17 MAJOR DIEP surgical kits (Model Nos. CCMJ73G-01 and CCMJ73H). The manufacturer is unable to confirm that product sterilization assurance requirements were met.
Without confirmed sterilization assurance, the devices carry a risk of loss or lack of functionality that may lead to delays or prolonged treatment. The affected devices are identified by UDI-DI numbers 00191072222824 and 00191072223890, and lot numbers 879241 and 70-052915.
The devices were distributed nationwide in Ohio.
The recalled product
- Product
- MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device
- Hazard
- sterilization-failure
- loss-of-functionality
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 00191072222824 00191072223890 Lots 879241 70-052915
Distribution
Distributed nationwide across the United States.
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