D&C Pack Recall Due to Sterilization Validation Failure
American Contract Systems is recalling D&C packs that were exposed to multiple sterilization cycles without proper validation. The sterilization failure may compromise device sterility.
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 device recall with no reported illnesses, injuries, or deaths. The hazard is a process validation failure that may compromise device sterility, representing a theoretical risk of harm rather than documented harm.
Plain-English summary
American Contract Systems, Inc. is recalling D&C packs distributed in the United States. The recalled devices were exposed to multiple sterilization cycles without validation for multiple exposures.
The sterilization process failure may compromise the device's sterility and integrity. Devices that have not been properly sterilized may pose a risk of infection or other complications when used in medical procedures.
The affected D&C packs were distributed to health systems and medical distributors in Arizona, Florida, Iowa, Illinois, Massachusetts, Minnesota, Missouri, Ohio, Nebraska, Pennsylvania, Rhode Island, South Dakota, and Texas. The specific affected lot included: Tray Number LLDC40G, Sterilization Lot 2108101, Lot Number 785211, and Bag Serial Number 44272963-005.
The recalled product
- Product
- D&C pack
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Surgical Pack
- Affected units
- 1
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 (7)
- Tray Number
- Sterilization Lot
- Lot Number
- Bag Serial Number 1) LLDC40G
- 2108101
- 785211
- 44272963-005
Distribution
Part of a larger recall action
This product is one of 17 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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