FDA Medical Device Recalls (openFDA)
Deroyal Surgical -Rose Hill: Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48''
- Recall number
- Z-1493-04
- Recalling firm
- Deroyal Surgical -Rose Hill
- Product
- Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48''
- 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
- 709 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: 1007212 1030172 1030181 1142043 1225324 1225332 1225341 1225359 1306298 1330669 1330677 1341190 1375832 1375841 1375867 1375875 1407072 1431304 1521772 1543672 1543681 1627016 1634152 1678542 1678606 1736079 1736087 1736095 1736108 1736116 1800384 1800608 1876426 1911375 1911421 2055689 2075217 2136454 2136471 2268684 2375877 728683 783421 805360 805378 805482 825555 900762 900797 900800 974681 974729
- 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