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Terminated

Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.

FDA Recall Z-2265-2020 · Posted None

Recalling FirmROi CPS LLC
Recall StatusTerminated
Product CodeFTN
Date Initiated2020-04-20
Date Terminated2020-08-21
Product Quantity40 Kits.

Reason for Recall

Custom procedure kits contains affected lots of PosiFlush Syringe, a product recalled by BD.

Firm Action

ROi CPS, LLC notified customer on 04/23/2020 via "Urgent Medical Device Recall Notice" The recall letter identified the affected product requested the users to review their inventory and quarantine the affected lots. The consignees were asked to complete and return the recall form.

Root Cause

Other

Distribution Pattern

US nationwide distribution in the states of MO, AR and OK.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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