Medline Breast Pack Kit regulatory clearance rescinded by FDA
The FDA has rescinded the regulatory clearance for Medline's Breast Pack Kit (Model DYNJ66777D) because certain Control Syringes, Guidewires, and High-Pressure Tubing components no longer meet regulatory standards.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 with regulatory clearance rescission as the basis. No illness, injury, or specific safety hazard has been reported in the source text; the issue is regulatory non-compliance, which qualifies as a precautionary moderate-severity recall.
Plain-English summary
Medline Industries, LP is recalling the Breast Pack Kit, Model Number DYNJ66777D (Lot 24JBX593), following rescission of its 510(k) regulatory clearance by the FDA. The clearance was withdrawn because certain Control Syringes, Guidewires, and/or High-Pressure Tubing components within the kit no longer comply with applicable regulatory requirements.
The affected product was distributed nationwide in the United States. Customers who have received this kit should contact Medline Industries, LP for guidance on return or replacement options. Use of this product should be discontinued pending receipt of instructions from the manufacturer.
The recalled product
- Product
- Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Surgical Kit
- Affected units
- 36
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) DYNJ66777D
- UDI-DI: 10195327365196(each)
- 40195327365197(case)
- Lot Number: 24JBX593
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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