The Recall Desk
HighFDA (Devices)·Z-1114-2023·Announced 2023-02-22

Surgical Breast Biopsy Kits Recalled Due to Non-Sterile Outer Wrapping

Medline Industries is recalling 60 units of its Breast Biopsy Kit nationwide because the outer wrapping is not sterile. Only the kit's contents maintain sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a surgical device with a sterility defect that creates a potential contamination risk. Although classified as FDA Class II, no illnesses or injuries have been reported. The hazard is theoretical but significant in a surgical context, matching the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Medline Industries, LP is recalling 60 units of its Breast Biopsy Kit (Reorder Number DYNDA1224B) distributed nationwide. The affected lot number is 22HMD545.

The kit is designed to provide sterile supplies for surgical breast biopsy procedures. However, due to a defect in the perforated bag wrapping, the outer surface of the kit is not sterile. Only the internal contents remain sterile.

This non-sterile outer wrapping could potentially allow contamination to affect the contents or the surgical field during use.

The recalled product

Product
Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kit
Hazard
  • sterility-defect
  • contamination-risk

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 (2)

  • GTIN 40193489468510
  • Lot # 22HMD545

Distribution

Distributed nationwide across the United States.

Related recalls

Same category