RegWardenFDA facility compliance records
Recall

Class II — American Contract Systems Inc

Recalling firmAmerican Contract Systems Inc
ClassificationClass II
StatusOngoing
ReasonThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
ProductAmerican Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10AP
Quantity30 units
DistributionUS Nationwide distribution in the states of IA, OH.
Initiated2026-06-29
Classified2026-08-21
Recall numberZ-3002-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — American Contract Systems Inc (Z-3002-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99514/

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