Custom Breast Biopsy Tray Recalled for Potential Particulate Matter
Custom Healthcare Systems is recalling breast biopsy trays because they may contain particulate matter in the included sodium chloride.
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: The recall involves a risk-of-harm product (particulate matter in injection pharmaceuticals) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 80 units of the Custom Breast Biopsy Tray w/Sodium Chloride (Catalog # B9-15263A). The recall is due to the possibility that the pharmaceuticals for injection packed in the trays may contain particulate matter.
The affected product is a sterile medical device used by physicians to perform breast biopsies. The specific lot number is 60812, with an expiration date of 11/2012. The product was distributed nationwide in the United States, including the states of Georgia, Ohio, North Carolina, and Maine.
Physicians and healthcare facilities should stop using the affected trays and contact Custom Healthcare Systems for instructions on returning the product.
The recalled product
- Product
- Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 80
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 NO. 60812 EXPIRES: 11 /2012
Distribution
Part of a larger recall action
This product is one of 2 recalled by Custom Healthcare Systems, Inc. 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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