Official recall record

CVS PCSU SJH, REF SJCV48J

US FDA — Medical Devices · 2023-09-01 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-09-01
Country of alert: United States
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00191072167903
Brand on record: American Contract Systems, Inc.

What the authority reported

During an internal investigation, ACS identified that the components, I.V. Cath (part number 4252535-02) and Adhesive Dermabond (part number DHVM12) were inadvertently subjected to the ACS sterilization process and exposed to EO and higher temperatures than approved by the component manufacturer. As a result, the components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) have higher than specified EO residuals.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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Other recalls from this brand

All 38 official recall notices naming American Contract Systems, Inc. on this site →

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