The Recall Desk
ModerateFDA (Devices)·Z-1183-2022·Announced 2022-06-08

Busse Hospital Swab Products Recalled for Manufacturing Validation Uncertainty

Busse Hospital Disposables is recalling swab and swabstick drug products due to uncertainty about whether manufacturing test methods were adequately validated. No illnesses or injuries have been reported.

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: FDA Class II classification establishes a baseline severity level. The hazard is based on manufacturing process validation uncertainty rather than confirmed contamination or defect. No illnesses or injuries reported. The theoretical nature of the risk aligns with precautionary recall classification.

Plain-English summary

Busse Hospital Disposables, Inc. is recalling swab and swabstick drug products manufactured by Professional Disposables International (PDI) that are sold in Busse Convenience kits. The recall is due to uncertainty regarding the adequacy of the validation of the test methods used during manufacturing.

The affected products were distributed nationwide and are identified by lot number 2010304. The U.S. Food and Drug Administration has classified this as a Class II recall.

Consumers with questions or who believe they may have received affected products should contact Busse Hospital Disposables, Inc. for further information.

The recalled product

Product
SS 3.5MM Pellet Insertion Tray with Medium Gloves Catalog Number: B1354
Manufacturer
Busse Hospital Disposables, Inc.
Category
Medical Device
Hazard
  • manufacturing-validation

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: 2010304 UDI: 00849233004641

Distribution

Distributed nationwide across the United States.

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