FDA Medical Device Recalls (openFDA)
Deroyal Surgical -Rose Hill: Stockinette, Single Ply Econo Weave, 8 X 72'', Ref #9999-72.
- Recall number
- Z-1491-04
- Recalling firm
- Deroyal Surgical -Rose Hill
- Product
- Stockinette, Single Ply Econo Weave, 8 X 72'', Ref #9999-72.
- Status
- Terminated
- Initiated
- 2004-09-09
- Posted
- 2004-09-29
- Terminated
- 2005-05-16
- Reason
- Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
- Root cause
- Other
- Action
- The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.
- Quantity
- 1 case
- Distribution
- Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.
- Lot, serial or model codes
- Lot: 1503929
- 510(k) numbers
- ["K030365"]
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 1046367
- Firm city
- Rose Hill
- Firm state
- VA
- 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