Medline CVC Barrier Kit Recalled for Breached Pouch Seals
Medline is recalling CVC barrier kits (Lot 22ABT774) due to breather pouches with seal openings that could compromise sterility of the surgical kit contents.
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: This is a Class II FDA medical device recall with no reported illnesses or injuries. However, the seal breach on sterile surgical equipment creates a risk-of-harm scenario where product sterility could be compromised before clinical use, potentially leading to infection or contamination during medical procedures.
Plain-English summary
Medline Industries is recalling the CVC Barrier Kit (model DYNJ80485, Lot 22ABT774) in response to customer complaints of breather pouches with openings in their seals.
A compromised seal on sterile surgical kit components could expose the contents to contamination, potentially affecting the safety and sterility of the product during medical procedures.
The recall affects approximately 50 kits distributed nationwide to healthcare facilities in California, Minnesota, North Carolina, New York, Oklahoma, Pennsylvania, Tennessee, and Texas.
Healthcare providers and patients who have received this product should contact Medline to determine if they have affected kits from the recalled lot. Affected product should not be used.
The recalled product
- Product
- MEDLINE CVC BARRIER KIT, REF DYNJ80485. Convenience kit used in medical procedures.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 50
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 (2)
- UDI/DI (01) 40195327045471
- Lot Number 22ABT774
Distribution
Part of a larger recall action
This product is one of 13 recalled by MEDLINE INDUSTRIES, LP - Northfield 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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