Z-1494-04

Stockinette, Double Ply, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Ref #9984-54...

Name: Z-1494-04 Stockinette, Double Ply, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Ref #9984-54...
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, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Ref #9984-54, #9984-54, #9985-60, #9986-72, #9987-48, #9988-60, #9988-72 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-1494-04
Status: Terminated
Initiated: 2004-09-09
Posted: 2004-09-29
Terminated: 2005-05-16
Recalling firm: Deroyal Surgical -Rose Hill
Product: Stockinette, Double Ply, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Ref #9984-54, #9984-54, #9985-60, #9986-72, #9987-48, #9988-60, #9988-72
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: 395 cases
Distribution: Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.
Product codes and lots: Lots: 9984-54 9985-60 9991-60 9986-72 9987-48 9988-72

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)