FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
- Recall number
- Z-2125-2014
- Recalling firm
- DeRoyal Industries Inc
- Product
- DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala
- Status
- Terminated
- Initiated
- 2014-06-04
- Posted
- 2014-07-29
- Terminated
- 2015-05-05
- Reason
- The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
- Root cause
- Packaging change control
- Action
- The recall was initiated by letter delivered via UPS on 6/4/2014. The firm requested that the consignee contact Stericycle to arrange for return and replacement of the product. A second notice was sent on 7/22/2014 to those accounts who did not respond to the initial notice. Distributors were requested to notify their end-users or provide a list of end-users to DeRoyal for direct notification. Effectiveness checks will be sent via email for those customers who have provided an email contact and via UPS for those customers who have not responded.
- Quantity
- 230 units
- Distribution
- Distributed in the states of MI, GA, OH, IL, MO, and IN.
- Lot, serial or model codes
- Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541
- 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