FDA Medical devices recall ·
CARROLLTON HIP FX Convenience kit used for surgical procedures… recall
- Recall number
- Z-0349-2025
- Date
- (initiated October 4, 2024)
- Company / brand
- Medline Industries, LP
3 Lakes Dr, Northfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 36 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI:10889942848447; Lot Number: 24EBP466
Distribution
US Nationwide distribution in the state of TN.
States: Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0349-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.