IV catheter components recalled for improper sterilization exposure
American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.
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: FDA Class II medical device with potential for loss of functionality and elevated chemical residuals. The hazard represents risk of harm to patients (improper IV delivery or adhesive failure) but no illnesses or injuries have been reported, limiting the score to 3 per the rubric for risk-of-harm products without reported injury.
Plain-English summary
American Contract Systems, Inc. is recalling 36 cases of CVS PCSU SJH, REF SJCV48J (UDI/DI 00191072167903), which includes I.V. catheter components (part number 4252535-02) and Adhesive Dermabond wound closure components (part number DHVM12). The product is distributed nationwide in Florida and Iowa under lot numbers 945231, 954231, and 974231.
During an internal investigation, the manufacturer identified that these components were inadvertently exposed to the sterilization process with ethylene oxide (EO) at higher temperatures than approved by the component supplier. This improper sterilization may result in loss or lack of functionality, loss of drug efficacy where applicable, and higher than specified EO residuals in the finished device.
No illnesses or injuries have been reported to date. Patients or healthcare facilities using these products should contact American Contract Systems, Inc. or their medical device supplier for instructions on product return or replacement. Do not use affected lots 945231, 954231, or 974231.
The recalled product
- Product
- CVS PCSU SJH, REF SJCV48J
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- improper-sterilization
- functionality-loss
- eo-residuals
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 00191072167903
- Lot Numbers: 945231
- 954231
- 974231
Distribution
Distributed nationwide across the United States.
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