FDA Recalls CVC Dressing Change Kit Due to Manufacturing Validation Uncertainty
Busse Hospital Disposables is recalling CVC Dressing Change Kits nationwide due to uncertainty about test method validation during manufacturing. Affected swab products may not have been adequately validated for sterility and efficacy.
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 recall affecting a sterile medical device used in clinical settings. The manufacturing validation uncertainty represents a risk of harm, as inadequately validated test methods could result in non-sterile or ineffective products. Although no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where injury has not yet been reported, supporting a High severity rating.
Plain-English summary
Busse Hospital Disposables has recalled CVC Dressing Change Kits (Catalog Number 2491R1) distributed nationwide. The kits contain swab and swabstick products manufactured by Professional Disposables International (PDI). The recall affects 200 units; lot numbers 2020472, 2020519, 2020651, and 2020759 are involved (UDI: 00849233004481).
The reason for the recall is uncertainty regarding the adequacy of test method validation used during manufacturing. Test methods are critical to verify that products meet quality standards for sterility, safety, and efficacy. If test methods themselves are not adequately validated, the reliability of the manufacturing quality assurance cannot be confirmed.
CVC Dressing Change Kits are sterile medical devices used in clinical settings. Healthcare facilities and individuals with affected product lots should discontinue use and contact Busse Hospital Disposables for instructions on replacement or corrective actions.
The recalled product
- Product
- CVC Dressing Change Kit Catalog Number: 2491R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Hazard
- manufacturing-validation
- sterilization-failure
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 (1)
- Lot Numbers: 2020472 2020519 2020651 2020759 UDI: 00849233004481
Distribution
Distributed nationwide across the United States.
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