Busse Hospital Disposables Recalls Convenience Kits with Swab Products
Busse Hospital Disposables is recalling Convenience kits containing swab products due to uncertainty about manufacturing validation adequacy. The kits were 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 an FDA Class II recall involving products used in medical and drug applications. Although no illnesses or injuries have been reported, the validation uncertainty means manufacturing defects have not been ruled out, qualifying this as a risk-of-harm product situation where injury has not yet been reported.
Plain-English summary
Busse Hospital Disposables, Inc. is recalling Busse Convenience kits that contain swab/swabstick drug products manufactured by Professional Disposables International. The kits have been distributed nationwide.
The recall is issued due to uncertainty regarding the adequacy of the validation of test methods used in manufacturing the products. This validation concern prevents confirmation that the manufacturing process met required standards. Lot Number 2130616 is identified by UDI 00849233006027.
Consumers who obtained the affected kits should discontinue use and consult their healthcare provider if they have questions about product exposure.
The recalled product
- Product
- Pellet Insertion Tray Catalog Number: B1654
- Manufacturer
- Busse Hospital Disposables, Inc.
- Category
- Drug
- Hazard
- Affected units
- 50
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: 2130616 UDI: 00849233006027
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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