Z-1041-03

ProVision Hytrel Universal Hood/Gown; product 5431-31-000

Name: Z-1041-03 ProVision Hytrel Universal Hood/Gown; product 5431-31-000
Creator: Depuy Orthopaedics, Inc.
Published: 2003-06-27
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2003-06-27 / Terminated / root cause: packaging

FDA source

Depuy Orthopaedics, Inc. began a recall of ProVision Hytrel Universal Hood/Gown; product 5431-31-000 on 2003-06-27. The reason FDA records is "Lack of assurance of sterility, due to the possibility of an incomplete package seal". 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-1041-03
Status: Terminated
Initiated: 2003-06-27
Posted: 2003-07-23
Terminated: 2004-02-04
Recalling firm: Depuy Orthopaedics Inc.
Product: ProVision Hytrel Universal Hood/Gown; product 5431-31-000
Product code: FYA Gown, Surgical
Reason for recall: Lack of assurance of sterility, due to the possibility of an incomplete package seal.
Root cause tag: packaging
FDA root cause: Other
Action: An Urgent Recall Notice was sent to customers on June 27, 2003 via federal express. Customers were instructed to locate all affected inventory and to immediately return it to Depuy.
Distribution: United States, Australia, Canada, Chile, England, India, Japan, Malaysia, Singapore, South Africa, Taiwan and United Kingdom
Product codes and lots: All product manufactured between February 1, 2002 and June 17, 2003 that does not have a green square on the label above the CE mark. Product bearing the green square on the label has been 100% inspected and is not under recall.

Product code FYA

K972832Class IIProvision Surgical Helmet SystemDepuy, Inc. / cleared 1997-10-21

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)