FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
- Recall number
- Z-0637-2018
- Recalling firm
- DeRoyal Industries Inc
- Product
- Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
- Status
- Terminated
- Initiated
- 2018-01-22
- Posted
- not on file
- Terminated
- 2020-08-19
- Reason
- DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve.
- Root cause
- Process change control
- Action
- The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 01/22/18 to its Consignees on 1/22/18 by overnight mail. The firm sent a follow-up "URGENT! RECALL NOTICE" letter dated 1/29/18. The letters described the product, problem and actions to be taken. The Consignees were instructed to identify affected products; place in quarantine; complete and return the Notice of Return Form, even if they no longer held any affected product, to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than 3/1/18, and return any product they held in stock. If you have further distributed these products, notify your customers of this recall. If you have questions or need assistance with the recall, please contact Regulatory Recall Coordinator and Quality Projects Manager at jmarsh@deroyal.com or by phone 865-362-4203 or email us at recalls@deroyal.com.
- Quantity
- 181 units
- Distribution
- US Distribution to: NY
- Lot, serial or model codes
- Lot numbers: 43097391, 43685581, 44750305, 45377442, 45464669, 45698684, 46203903
- 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