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Terminated

DeRoyal Heart Cath Procedure Pack, REF 89-6556.08

FDA Recall Z-1833-2021 · Posted 2021-06-10

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2021-05-14
Date Terminated2023-04-21
Product Quantity66 packs

Reason for Recall

DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine

Firm Action

The firm initiated the recall by email on May 14, 2021. The notice explained the problem and hazard,. Customers were instructed to complete the NOTICE OF RETURN FORM-CREDIT ONLY, indicating all affected products found in your inventory. and return to DeRoyal via fax to 865-362-3716 or [email protected] Customers were asked to PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. Distributors were instructed to notify their customers.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide distribution to the states of MS, VA, LA, and NY.

Official Source

View FDA Recall →

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

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