Swab Drug Products Recalled Due to Manufacturing Validation Uncertainty
Convenience kits containing swab/swabstick drug products are being recalled due to uncertainty about whether test methods used during manufacturing adequately validated the products. Affected products include 80 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: FDA Class II classification indicates products subject to regulatory controls due to potential health risks. No illnesses or injuries have been reported. However, manufacturing validation uncertainty for medical swab products used in healthcare settings represents a fundamental quality control issue affecting product safety assurance, fitting the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Convenience kits containing swab/swabstick drug products due to manufacturing validation concerns. The affected products include 80 units distributed nationwide with lot numbers 2130426, 2130801, 2131032, 2131138, and 2131290 (UDI: 00849233006546). The swab/swabstick products were manufactured by Professional Disposables International (PDI).
The recall was initiated due to uncertainty regarding the adequacy of the validation of the test methods used to manufacture these drug products. This means the company cannot confirm that the manufacturing process validation was sufficient.
Affected consumers and healthcare facilities should stop using the recalled kits immediately and contact Busse Hospital Disposables, Inc. for information about product return or disposal. No illnesses or injuries have been reported in connection with these products.
The recalled product
- Product
- Epidural Tray Catalog 1577
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug — Medical Swabs
- Hazard
- validation-uncertainty
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: 2130426 2130801 2131032 2131138 2131290 UDI: 00849233006546
Distribution
Distributed nationwide across the United States.
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