Custom US Breast Core Biopsy Tray Recalled for Sterility Concerns
Custom Medical Specialties is recalling 25 breast biopsy trays because they contain saline bags subject to a separate recall for leaking.
The agency’s classification
FDA (Drugs): 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II, and the hazard involves a lack of assurance of sterility in a medical device, which aligns with the 'Severe' criteria for significant injury risk or structural defects.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 25 units of the CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile. The product is identified by Lot # 26124-1112 and has an expiration date of 12/2012.
The recall was initiated due to a lack of assurance of sterility. The medical trays contain Hospira 0.9% Sodium Chloride bags that were previously subject to a recall due to leaking bags. The affected units were distributed in Georgia, Maryland, and Massachusetts.
The FDA has classified this recall as Class II. Consumers and healthcare providers should stop using the affected trays and contact the manufacturer for further instructions.
The recalled product
- Product
- CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Manufactured by: CMS Custom Medical Specialties, Inc., 330 East Main St, PO Box 177, Pine Level, NC 27568, the tray also contains other components not listed in this product…
- Manufacturer
- Custom Medical Specialties, Inc.
- Category
- Medical Device — Biopsy Tray
- Affected units
- 25
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)
- Lot #: 26124-1112
- Exp 12/2012
Distribution
Part of a larger recall action
This product is one of 3 recalled by Custom Medical Specialties, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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