Custom Medical Specialties Recalls Biopsy Trays with Syringes Due to Sterility Concerns
Custom Medical Specialties is recalling 80 biopsy trays containing syringes because the sterility of the syringes could not be assured. The affected products were distributed to Idaho and Oregon.
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: The recall is classified as FDA Class II. The hazard involves a risk of harm (loss of sterility) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 80 units of CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Trays. These trays contain a BD 10cc LL Syringe, Sterile. The recall is being conducted because the sterility of the syringe product could not be assured.
The affected products are identified by Lots 40629-1609 and 40631-1609. The distribution pattern for this recall is US Distribution to Idaho (ID) and Oregon (OR).
Healthcare facilities and consumers who have these specific products should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
- Manufacturer
- Custom Medical Specialties, Inc.
- 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)
- Lots 40629-1609 an 40631-1609
Distribution
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