DeRoyal Industries Inc DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
Brand
DeRoyal Industries Inc
Lot Codes / Batch Numbers
Lot Numbers: 54310362, exp. 01/01/2022, 54366825, exp. 01/01/2022
Products Sold
Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022
DeRoyal Industries Inc is recalling DeRoyal Heart Cath Procedure Pack, REF 89-6556.08 due to DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabe. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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 recalls@deroyal.com 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026