Busse Convenience Kit Swab Products Recalled Due to Manufacturing Test Validation Issue
Busse Convenience kits containing swab/swabstick products manufactured by Professional Disposables International have been recalled due to uncertainty about the adequacy of manufacturing test method validation.
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 medical device recall with no reported illnesses or injuries. The hazard involves uncertainty regarding the adequacy of manufacturing test method validation, representing a potential risk-of-harm in medical devices. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).
Plain-English summary
Busse Convenience kits containing one or more swab/swabstick products manufactured by Professional Disposables International (PDI) are subject to recall.
The recall was initiated due to uncertainty regarding the adequacy of the validation of the test methods used in manufacturing these products.
The affected products are identified by Lot Number 2010337 (UDI: 00849233006515). A total of 30 units were distributed nationwide.
The recalled product
- Product
- SS 4.5MM Pellet Insertion Tray with Large Gloves Catalog Number: B1363
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 30
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: 2010337 UDI:00849233006515
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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