Busse Convenience Kits With Swab Products Recalled for Manufacturing Validation Issues
Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are recalled due to uncertainty about manufacturing test method validation.
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: Per the rubric, risk-of-harm products without reported injury score as High (3). Manufacturing validation uncertainty on drug/medical swab products represents a risk-of-harm situation with no illnesses or injuries reported in the source.
Plain-English summary
Busse Convenience kits containing one or more swab/swabstick drug products manufactured by Professional Disposables International (PDI) have been recalled.
The recall was issued due to uncertainty regarding the adequacy of validation of the test methods used during manufacturing of these drug products.
The recalled kits were distributed nationwide. The affected lot numbers are 2031076 and 2130823 with UDI 00849233017306. Approximately 99 units were recalled.
The recalled product
- Product
- 4.5 MM Pellet Insertion Tray Catalog Number: B8121R1
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- Hazard
- Affected units
- 99
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: 2031076 2130823 UDI:00849233017306
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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