Medline D and C Pack Kits Recalled Due to Rescinded Regulatory Clearances
Medline Industries is recalling D and C Pack kits (Model DYNJ41254B) nationwide because regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving rescission of regulatory clearances for medical device components. No injuries or illnesses have been reported, and the recall is precautionary in nature related to regulatory status rather than an identified defect or contamination.
Plain-English summary
Medline Industries, LP is recalling the D and C Pack (Model Number DYNJ41254B) distributed nationwide in the United States. The recall was initiated because the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing components included in these kits have been rescinded by the FDA.
Affected units bear the model number DYNJ41254B with Lot Number 25FBA224. The UDI-DI identifiers are 10888277882003 (each) and 40888277882004 (case).
Customers who have received this product should contact Medline Industries, LP for further instructions regarding return or replacement of affected kits.
The recalled product
- Product
- Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
- Manufacturer
- Medline Industries, LP
- Hazard
- regulatory-non-compliance
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 (4)
- 1) DYNJ41254B
- UDI-DI: 10888277882003(each)
- 40888277882004(case)
- Lot Number: 25FBA224
Distribution
Distributed nationwide across the United States.
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