Medical Device Packs Recalled for Improper Sterilization Process
American Contract Systems recalled General Pack medical device components (I.V. catheters and adhesive) that were improperly sterilized with ethylene oxide at higher than approved temperatures. The components may lack functionality or have elevated sterilization 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: FDA Class II recall of medical device components with potential loss of functionality due to improper sterilization. The hazard is theoretical with no reported illnesses or injuries mentioned in the source, fitting the 'risk-of-harm product where injury has not yet been reported' criterion for High severity.
Plain-English summary
American Contract Systems, Inc. is recalling General Pack medical device components (REF BBGP31C, Lot 968231). The recalled items include intravenous catheters (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) contained in 57 cases distributed nationwide to Florida and Iowa.
The components were inadvertently subjected to the company's sterilization process using ethylene oxide gas at temperatures higher than approved by the component manufacturers. As a result, the components may have loss or lack of functionality, loss of drug efficacy if applicable, and higher than specified ethylene oxide residuals.
American Contract Systems identified this issue during an internal investigation. Consumers and healthcare providers should not use the affected components and should contact the company for instructions on replacement or return.
The recalled product
- Product
- General Pack, REF BBGP31C
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 57
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 (2)
- UDI/DI 00191072166609
- Lot Number 968231
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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