FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
- Recall number
- Z-1833-2021
- Recalling firm
- DeRoyal Industries Inc
- Product
- DeRoyal Heart Cath Procedure Pack, REF 89-6556.08
- Status
- Terminated
- Initiated
- 2021-05-14
- Posted
- 2021-06-10
- Terminated
- 2023-04-21
- Reason
- 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
- Root cause
- Nonconforming Material/Component
- 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 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.
- Quantity
- 66 packs
- Distribution
- US Nationwide distribution to the states of MS, VA, LA, and NY.
- Lot, serial or model codes
- Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28