Convenience Kits With Swab Drug Products Recalled for Test Validation Failure
Busse Convenience kits containing swab/swabstick drug products from Professional Disposables International are being recalled due to inadequate validation of manufacturing test methods.
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 an FDA Class II medical device recall involving an unvalidated manufacturing process. Although no illnesses or injuries have been reported, the failure to properly validate test methods represents a meaningful risk-of-harm for products used in medical applications, meeting the rubric criterion for High severity.
Plain-English summary
Busse Convenience kits containing one or more swab/swabstick drug products manufactured by Professional Disposables International (PDI) are being recalled due to uncertainty about the adequacy of the validation of the test methods used to manufacture these products.
The recall addresses a manufacturing quality control issue: the test methods employed during production were not properly validated, raising the possibility that products may not meet intended specifications.
No illnesses or injuries have been reported to date. Affected healthcare facilities and providers should contact their suppliers regarding the recall and any necessary corrective actions.
The recalled product
- Product
- Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Affected units
- 360
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: 2031047 2031162 2130578 2130723 UDI: 00849233011151
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 recalled by Busse Hospital Disposables, Inc. 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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