DeRoyal Angio Cath Removal Tray, REF 89-9936.02
FDA device recall Z-1834-2021 · posted 2021-06-10 · Terminated
Recall details
- Recalling firm
- DeRoyal Industries Inc
- 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
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 60 trays
- Distribution
- US Nationwide distribution to the states of MS, VA, LA, and NY.
- Date initiated
- 2021-05-14
- Date posted
- 2021-06-10
- Date terminated
- 2023-04-21
- Location
- Powell, TN
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