FDA Medical Device Recalls (openFDA)
Molnlycke Health Care Inc: Barrier Hip Sheet with Side Pockets
- Recall number
- Z-1137-03
- Recalling firm
- Molnlycke Health Care Inc
- Product
- Barrier Hip Sheet with Side Pockets
- Status
- Terminated
- Initiated
- 2003-07-14
- Posted
- 2003-08-14
- Terminated
- 2003-11-10
- Reason
- pouch may tear which could result in contamination of sterile field
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K780282"]
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 2523357
- Firm city
- Newton Pa
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28