Breast Plastics Pack Recalled for Potential Loss of Functionality Due to Sterilization Process
American Contract Systems is recalling Breast Plastics Pack components because they were subjected to inappropriate sterilization that may cause loss of functionality or drug efficacy and increased ethylene oxide residuals.
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 FDA Class II recall involves a risk of device malfunction and potential loss of drug efficacy due to improper sterilization with elevated ethylene oxide exposure. No illnesses or injuries have been reported, and the potential harms are theoretical rather than confirmed, making this a risk-of-harm product without reported injury.
Plain-English summary
American Contract Systems, Inc. is recalling the Breast Plastics Pack, REF BBPL20D (UDI/DI 00191072166241). The recall involves components including I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12). Approximately 20 cases distributed nationwide to Florida and Iowa are affected.
During an internal investigation, American Contract Systems identified that these components were inadvertently subjected to the company's sterilization process using ethylene oxide (EO) at temperatures higher than approved by the component manufacturer. As a result, the components may have loss or lack of functionality, loss of drug efficacy if applicable, and higher than specified EO residuals.
Healthcare facilities and distributors in Florida and Iowa that received affected lot numbers 756221, 782221, or 862221 should stop using these products and contact American Contract Systems for further instructions. Healthcare providers and patients who may have received products from affected lots should consult with their healthcare provider.
The recalled product
- Product
- Breast Plastics Pack, REF BBPL20D
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device
- Affected units
- 20
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 (4)
- UDI/DI 00191072166241
- Lot Numbers: 756221
- 782221
- 862221
Distribution
Part of a larger recall action
This product is one of 12 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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