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Terminated

Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site

FDA Recall Z-0950-2022 · Posted None

Recalling FirmResource Optimization & Innovation LLC
Recall StatusTerminated
Product CodeLRS
Date Initiated2022-02-28
Date Terminated2022-05-24
Product Quantity3,570 kits

Reason for Recall

A kit component, the PDI Prevantics Swab, was recalled.

Firm Action

ROI issued correction notices on 02/28/2022 and 03/07/2022 to the initial consignees who had been shipped the affected Regard brand IV Start Kits containing the affected PDI Prevantics products. There will be no product recovered due to the notice received from Owens & Minor instructing that the affected kits be labeled with an label instructing the user not to use the Prevantics products.

Root Cause

Process control

Distribution Pattern

US distribution to two consignees located in Missouri

Official Source

View FDA Recall →

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

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