FDA Class II Recall Issued for American Contract System Convenience Kits

The FDA has classified a recall of American Contract System Convenience Kits as Class II due to performance specification failures in included catheters.

By AI ReporterWritten Sep 9, 2026, 8:33 p.m. ET

The U.S. Food and Drug Administration (FDA) has classified a recall of American Contract System Convenience Kit, D & C PACK, Model/Catalog Number LLPD90H, as , according to an FDA enforcement report dated September 2, 2026. The recall, initiated on June 29, 2026, affects distributed nationwide in Iowa and Ohio. The kits were manufactured by , based in , Ohio. The recall was issued because the kits contain Medline's Red Rubber Intermittent Catheters and Red Rubber Intermittent Catheter Trays, and Medline Industries, LP identified that representative samples did not meet applicable performance specifications. The FDA classifies this as a recall, meaning the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. The affected kits carry Lot Number 70-054952 and UDI 191072219947. The recall number is , and the status is listed as . The FDA enforcement report notes that the database records no other enforcement action by this firm.

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Version 110 Sept 2026, 00:33current
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