FDA Medical Device Recalls (openFDA)
Deroyal Surgical -Rose Hill: Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large, 16'' X 48'', Ref #9978-16
- Recall number
- Z-1490-04
- Recalling firm
- Deroyal Surgical -Rose Hill
- Product
- Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large, 16'' X 48'', Ref #9978-16
- 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
- 1971 cases
- Distribution
- Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.
- Lot, serial or model codes
- Lot # 1007298 1007335 1007360 1030228 1030244 1045526 1049113 1081519 1107441 1141972 1161316 1161332 1200979 1225252 1306538 1310369 1315021 1330597 1330600 1342811 1375681 1375808 1375816 1490540 1504008 1504032 1521713 1543630 1571438 1650988 1736028 1759511 1802072 1911543 1911615 2076658 2076738 2137810 2137828 2138062 2187067 2228121 2376204 2701345 765821 765855 804316 805431 805440 825580 825598 825635 825643 850507 900691 932991 933071 933097 933118 933151 950663 950680 950743 974585 974593 974665
- 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