The Recall Desk
ModerateFDA (Devices)·Z-1200-2022·Announced 2022-06-08

Swab and Swabstick Drug Products Recall Due to Manufacturing Test Validation Uncertainty

Busse Convenience kits containing swab and swabstick drug products manufactured by PDI are recalled due to uncertainty about manufacturing test method validation. No illnesses 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: This is an FDA Class II recall with no reported illnesses or injuries. The issue concerns uncertainty about manufacturing test method validation, making this a precautionary recall.

Plain-English summary

Busse Convenience kits contain swab and swabstick drug products manufactured by Professional Disposables International (PDI) that are subject to recall. These products are distributed nationwide.

The recall is due to uncertainty regarding the adequacy of the validation of test methods used to manufacture these drug products. No illnesses or injuries have been reported.

The recalled product

Product
SS 4.5MM Pellet Insertion Tray Catalog Number:B8128R1
Manufacturer
Busse Hospital Disposables, Inc.
Category
Drug
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: 2130197 UDI: 00849233001855

Distribution

Distributed nationwide across the United States.

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