Medline Total Hip Kit Recalled for Expired Prep Solution
Medline is recalling the Total Hip Kit (REF DYNJ903275S) because the included prep solution expires before the kit itself expires. Sixteen kits with lot code 23CDC733 were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries or illnesses. The hazard—an expired prep solution in a surgical kit—constitutes a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
Medline Industries is recalling the Total Hip Kit (REF DYNJ903275S), a surgical convenience kit. The recall was initiated because the prep solution included in the kit expires prior to the expiration date of the kit.
The affected product has lot code 23CDC733. A total of 16 kits were distributed nationwide, including in Illinois.
Healthcare facilities and surgical providers should immediately discontinue use of the affected lot and contact Medline Industries for replacement product. Units with lot code 23CDC733 should be withdrawn from inventory.
The recalled product
- Product
- Total Hip Kit, REF DYNJ903275S; surgical convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kit
- Hazard
- expired-solution
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI: 10195327254582 (unit)
- 40195327254583 (case)
- Lot code 23CDC733
Distribution
Distributed nationwide across the United States.
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