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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 60
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.
Part of a larger recall action
This product is one of 20 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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