Custom Medical Specialties Recalls Sterile Access Trays Due to Sterility Concerns
Custom Medical Specialties is recalling 35 sterile access trays because they contain sodium chloride bags subject to a separate recall for leaking.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical device, which aligns with the criteria for a Severe rating due to the risk of infection.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 35 units of the Custom Access Tray, Sterile, Re-order #: CMS-1667-R2(94-2478). The product is manufactured for KM Medical, Inc. and contains Sodium Chloride 0.9% 50 mL bags along with other components.
The recall is being conducted 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 specific lot number is 25744-1111, with an expiration date of 09/2012.
The affected products were distributed in Georgia, Maryland, and Massachusetts. Consumers and healthcare facilities should stop using the product and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description.
- Manufacturer
- Custom Medical Specialties, Inc.
- Category
- Medical Device — Surgical Trays
- Affected units
- 35
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 #: 25744-1111
- Exp 09/2012
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.
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