Central Line Dressing Kit Component Has Shorter Expiration Than Kit Label
Medical Action Industries recalls Central Line Dressing Change kits because the ChloraPrep 3ml component expires sooner than the kit label indicates. Users should discontinue use and contact their supplier.
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 3/5 (High).
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: FDA Class II medical device recall involving an expiration dating discrepancy on a kit component used in clinical procedures. No illnesses or injuries reported, qualifying this as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medical Action Industries, Inc. is recalling Central Line Dressing Change kits (Product Code 59815B, Batch 0000285665, Kit expiration date 03/31/2024, UDI: 20809160170523) due to an expiration dating discrepancy. The ChloraPrep 3ml component included in the kit has an actual expiration date earlier than the date printed on the kit's outer packaging.
This dating mismatch could cause users to inadvertently employ an expired component during central line dressing change procedures, relying on the kit's labeled expiration date. The affected product includes 42 cases distributed to a single medical device distributor in Michigan.
No illnesses or injuries have been reported in connection with this recall.
Users with affected product should stop using it immediately and contact their distributor or Medical Action Industries for replacement or return instructions.
The recalled product
- Product
- Kit: Central Line Dres Change 20/Cs
- Manufacturer
- Medical Action Industries, Inc. 306
- Affected units
- 42
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)
- Product Code: 59815B
- Batch 0000285665
- Kit expiration date 03/31/2024 UDI: 20809160170523
Distribution
Distributed in 1 state:
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