The Recall Desk
ModerateFDA (Devices)·Z-1190-2022·Announced 2022-06-08

FDA Recalls Swab Products for Manufacturing Validation Uncertainty

Busse Convenience kits containing swab/swabstick products from Professional Disposables International have been recalled by the FDA due to uncertainty about adequate validation of manufacturing test methods.

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 recall addresses manufacturing test method validation uncertainty, a quality-control issue rather than a specific identified hazard.

Plain-English summary

The FDA has recalled Busse Convenience kits containing swab/swabstick products manufactured by Professional Disposables International (PDI). The affected products are identified by lot numbers 2110054 and 2110116, with UDI 00849233005365, with 60 units distributed nationwide.

The recall was initiated due to uncertainty regarding the adequacy of validation of the test methods used to manufacture these products. This represents a quality-control concern about whether the manufacturing process was properly validated according to FDA standards.

Healthcare facilities and users of these products should contact Busse Hospital Disposables, Inc., the recalling firm, for information regarding return or disposal of affected units.

The recalled product

Product
SS 3.5MM Diamond Tip Trocar - Large Gloves Catalog Number: B1547
Manufacturer
Busse Hospital Disposables, Inc.
Category
Medical Device
Hazard
  • manufacturing-defect

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: 2110054 2110116 UDI: 00849233005365

Distribution

Distributed nationwide across the United States.

Related recalls

Same category