I.V. Start Kit Recall Due to Uncertain Manufacturing Process Validation
Busse Hospital Disposables is recalling I.V. Start Kit (Catalog 8172) due to inadequate validation of manufacturing processes for the included swab drug products. The recall affects 4,218 units distributed nationwide.
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 a Class II FDA recall of drug products used in medical administration with uncertain manufacturing process validation. Although no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling I.V. Start Kit Catalog 8172 units. These kits contain swab and swabstick drug products manufactured by Professional Disposables International (PDI). The recall was initiated because there is uncertainty regarding the adequacy of the validation of the test methods used to manufacture these drug components.
The recall affects approximately 4,218 units that were distributed nationwide. The affected lot numbers include: 2020561, 2020560, 2020650, 2120089, 2120018, 2120344, 2120442, 2120645, 2120768, and 2120911.
Consumers and healthcare facilities that have these kits should discontinue use and contact Busse Hospital Disposables for instructions on returns or replacement. No illnesses or injuries have been reported to date in connection with this recall, though the uncertain validation of manufacturing processes represents a potential risk for users of these medical kits.
The recalled product
- Product
- I.V. Start Kit Catalog 8172
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- Hazard
- validation-failure
- contamination-risk
Distribution
Distributed nationwide across the United States.
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