The Recall Desk
ModerateFDA (Devices)·Z-1182-2022·Announced 2022-06-08

Busse Convenience Kits Recalled for Manufacturing Test Method Validation Uncertainty

Busse Convenience kits containing swab and swabstick products manufactured by Professional Disposables International are recalled by the FDA due to uncertainty regarding the 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 a Class II FDA recall based on validation uncertainty in manufacturing test methods. No illnesses or injuries are reported, and no specific product defect has been identified. The recall is precautionary in addressing a manufacturing process quality control issue.

Plain-English summary

Busse Convenience kits containing swab and swabstick medical products manufactured by Professional Disposables International (PDI) are subject to a Class II FDA recall. The product catalog number is B1352R1, distributed nationwide as 120 units across lot numbers 2110100, 2110083, 2110226, and 2110262.

The recall was initiated because of uncertainty regarding the adequacy of the validation of the test methods used during manufacturing. The FDA issued this recall to address concerns about whether the manufacturing processes used to ensure product quality were themselves adequately validated.

The recalled product

Product
SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
Manufacturer
Busse Hospital Disposables, Inc.
Category
Medical Device — Specimen Collection / Swabs
Hazard
  • test-method-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: 2110100 2110083 2110226 2110262 UDI: 00849233004719

Distribution

Distributed nationwide across the United States.

Related recalls

Same category