FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
- Recall number
- Z-0349-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
- Status
- Open, Classified
- Initiated
- 2024-10-04
- Posted
- 2024-11-08
- Terminated
- not on file
- Reason
- Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
- Root cause
- Nonconforming Material/Component
- Action
- An URGENT MEDICAL DEVICE NOTIFICATION dated 10/4/24 was sent to the customer. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately.2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.The login for completing the response form is:Website link: https://recalls.medline.comRecall Reference #: R-24-207-FGX1Recall Code: 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Quantity
- 36 units
- Distribution
- US Nationwide distribution in the state of TN.
- Lot, serial or model codes
- UDI-DI:10889942848447; Lot Number: 24EBP466
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OJH
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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