Busse Laceration Tray Recall Due to Foreign Matter
Busse Hospital Disposables is recalling Laceration Trays because they may contain loose polypropylene foreign matter above release specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves foreign matter contamination without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables is recalling 75 cases of Laceration Trays, Catalog # 1892R1. The product is used for surgical procedures and was distributed nationwide in the United States.
The recall was initiated because the trays may contain loose polypropylene foreign matter that exceeds release specifications. The affected lots have expiration dates ranging from 2020 to 2021.
Healthcare facilities and consumers should stop using these specific trays and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure
- Hazard
- Affected units
- 75
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 (5)
- Lot Numbers/Expiration Dates: 1) 1730650/Expiration Date: 10/30/2021
- 2) 1630921/Expiration Date: 11/02/2020
- 3) 1631124/Expiration Date: 10/30/2020
- 4) 1631386/Expiration Date: 05/30/2021
- 5) 1631679/Expiration Date: 05/30/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables 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.
See all 7 products in this recall →Related recalls
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