The Recall Desk
ModerateFDA (Devices)·Z-0544-2018·Announced 2018-02-14

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.

What this means for you

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
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 →

Same manufacturer · Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables

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