FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
- Recall number
- Z-2678-2016
- Recalling firm
- DeRoyal Industries Inc
- Product
- Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
- Status
- Terminated
- Initiated
- 2016-08-11
- Posted
- 2016-08-26
- Terminated
- 2017-06-13
- Reason
- The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
- Root cause
- Nonconforming Material/Component
- Action
- DeRoyal issued their recall on 08/11/2016 to the end-user level by sending overnight letters to its direct accounts. The customers were asked to identify the affected trays, place them in quarantine and return them to DeRoyal for replacement or credit.
- Quantity
- 26 units
- Distribution
- Distributed in LA and TN.
- Lot, serial or model codes
- Lot Number 40259236
- 510(k) numbers
- ["K842648"]
- 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