FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
- Recall number
- Z-1870-2016
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
- Status
- Terminated
- Initiated
- 2016-03-21
- Posted
- not on file
- Terminated
- 2016-08-16
- Reason
- These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
- Root cause
- Packaging
- Action
- Aligned Medical Solutions (AMS) sent the Urgent Medical Device Recall letter, dated March 21, 2016, and the Recall Reply Form to their consignees via email. AMS informed consignees that their AMS packs (surgical kits) contained Kerlix X-Ray Detectable Laparotomy Sponge which was recalled by Medtronic. Consignees were advised to follow the over-labeling instructions and dispose the Kerlix X-Ray Detectable Laparotomy Sponge at the time the surgical kit is opened for use. Consigneeswere instructed to follow the "Instruction for placing Recall Notice Label to Packs" and label any kits remaining inventory. Consignees should return the Reply Form via fax at 407-865-7456 or call 321-527-7714 for any questions about this recall.
- Quantity
- 170 units
- Distribution
- Nationwide distribution to Louisiana and Montana.
- Lot, serial or model codes
- lot 56402, 57255, 60542, and 61506
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRS
- Firm FEI
- 1000125955
- Firm city
- Billings
- Firm state
- MT
- 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