Z-1493-04

Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48''

Name: Z-1493-04 Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48''
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 Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48'' 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-1493-04
Status: Terminated
Initiated: 2004-09-09
Posted: 2004-09-29
Terminated: 2005-05-16
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''
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: 709 cases
Distribution: Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.
Product codes and lots: 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

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)