Z-1490-04

Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large...

Name: Z-1490-04 Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large...
Creator: Deroyal Surgical -Rose Hill
Published: 2004-09-09
License: https://open.fda.gov/license/

Deroyal Surgical -Rose Hill / initiated 2004-09-09 / Terminated / root cause: packaging

FDA source

Deroyal Surgical -Rose Hill began a recall of 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 on 2004-09-09. The reason FDA records is "Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1490-04
Status: Terminated
Initiated: 2004-09-09
Posted: 2004-09-29
Terminated: 2005-05-16
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
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
Root cause tag: packaging
FDA 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 in commerce: 1971 cases
Distribution: Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.
Product codes and lots: 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

Product code KKX

K030365Class IIDeroyal Drapes, Sterile, Non-SterileDeroyal Industries, Inc. / cleared 2003-04-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)