# FDA recall Z-2440-2021 > **Copan Italia** · Class II · device recall initiated 2021-07-09. ## Product COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind. wrapped., bp 60mm, bundles of 20; REF: 502CS01, Regular, Sterile single Wrapped, Molded bp 80mm; REF: 503CS01, Flexible, Sterile Single Wrapped, Molded bp 100mm; REF: 220252, P/N 503CS01.BD, Flexible, Sterile Single Wrapped Molded bp 100 mm; REF: 503CS01/503CS01.BX, Flexible, Sterile Single Wrapped, Molded bp 100mm REF: 50U004DS, hDNA Free, Regular sterile in dry tube Molded Break Point 20 mm; REF: 50U009DS02, hDNA Free, Regular, Sterile, 2pcs Packed; REF: 518CS01, Minitip, Ster. Single Wrapped, Molded bp 100mm; REF: 220251, P/N: 518CS01.BD, Minitip, sterile Single Wrapped Molded bp 100mm; REF: 519C/519C.BX, Regular Sterile, Molded break point 100 m ## Reason for recall A sterility assurance level of 10-6 cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano. ## Distribution US nationwide distribution, including Puerto Rico. ## Key facts - **Recall number:** Z-2440-2021 - **Recalling firm:** Copan Italia - **Classification:** Class II - **Product type:** device - **Status:** Terminated - **Initiation date:** 2021-07-09 - **Report date:** 2021-09-15 - **Termination date:** 2024-01-25 - **Voluntary/Mandated:** Voluntary: Firm initiated - **Location:** Brescia, N/A, Italy ## Primary source FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2440-2021 ## Citation > AI Analytics. FDA recall Z-2440-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2440-2021. Source: US FDA. Licensed CC0. --- *[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*