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Terminated

Regard brand CABG Pack A and B - Spartanburg

FDA Recall Z-1051-2022 · Posted None

Recalling FirmROi CPS LLC
Recall StatusTerminated
Product CodeOEZ
Date Initiated2022-03-21
Date Terminated2023-12-28
Product Quantity85 kits

Reason for Recall

Kits were packed into shipping boxes incorrectly.

Firm Action

An email notification of the recall was sent to the single impacted consignee (a distributor) on 03/29/2022. The consignee was instructed to complete the following: 1) Check: Please review inventory and determine if affected product is inventory. 2) Quarantine: Kits containing a special inspection label are approved to be used. Only quarantine and report kits that do not have this special label. If unlabeled kits are identified, immediately quarantine and do not further distribute. 3) Reply: Complete reply form indicating the number of kits in quarantine. Send the reply to [email protected] so a return can be arranged. 4) Notify: Notify immediately any customers to whom you have distributed or forwarded product affected by this recall. Include the recall letter to supplement your notification.

Root Cause

Under Investigation by firm

Distribution Pattern

Recall impacted one domestic consignee in NC

Official Source

View FDA Recall →

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

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