Z-1137-03

Barrier Hip Sheet with Side Pockets

Name: Z-1137-03 Barrier Hip Sheet with Side Pockets
Creator: Molnlycke Health Care Inc
Published: 2003-07-14
License: https://open.fda.gov/license/

Molnlycke Health Care / initiated 2003-07-14 / Terminated / root cause: packaging

FDA source

Molnlycke Health Care Inc began a recall of Barrier Hip Sheet with Side Pockets on 2003-07-14. The reason FDA records is "pouch may tear which could result in contamination of sterile field". 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-1137-03
Status: Terminated
Initiated: 2003-07-14
Posted: 2003-08-14
Terminated: 2003-11-10
Recalling firm: Molnlycke Health Care
Product: Barrier Hip Sheet with Side Pockets
Product code: KKX Drape, Surgical, Antimicrobial
Reason for recall: pouch may tear which could result in contamination of sterile field
Root cause tag: packaging
FDA root cause: Other
Action: The recalling firm issued recall letters dated 7/9/03 to their direct accounts informing them of the problem/reason for recall, the need to return the product and to contact their customers regarding the recall.
Quantity in commerce: 2714 units
Distribution: The products were shipped to distributors, hospitals, and sales representatives nationwide. The product was also shipped to dealers in Australia, New Zealand, Canada, and Belgium.
Product codes and lots: Product Code 0202 Lot numbers 03149759 and 03165584. Product Code 0204 Lot numbers 030305, 030321, and 03165583. Product Code 9202 Lot numbers 250203, 03205562, and 03255432.

Product code KKX

K780282Barrier Hip Pack W/ Fabric 450Surgikos, Inc. / cleared 1978-02-28

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)