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Open, Classified

Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478

FDA Recall Z-2088-2023 · Posted 2023-07-03

Recalling FirmDeRoyal Industries Inc
Recall StatusOpen, Classified
Product CodeKDD
Date Initiated2023-05-30
Product Quantity328 packs

Reason for Recall

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Firm Action

DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

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

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