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Terminated

Isolation Droplet Bundle Kit

FDA Recall Z-2465-2020 · Posted None

Recalling FirmROi CPS LLC
Recall StatusTerminated
Product CodeOEA
Date Initiated2020-05-19
Date Terminated2020-09-01
Product Quantity24 kits

Reason for Recall

Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.

Firm Action

On May 19, 2020 Roi CPS LLC notified its customers to review their inventory to determine if the custom procedure kit item and lot identified were on their inventory. If identified, please quarantine and notify Roi of the quantity on hand completing the reply form provided to them via email and to forward this notification to all potential user of the recall.

Root Cause

Error in labeling

Distribution Pattern

Domestic distribution only to: MO and LA.

Official Source

View FDA Recall →

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

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