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.
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: 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
- Affected units
- 17
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
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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