Custom Medical Specialties Recalls CMS-2890 Needle Local Trays
Custom Medical Specialties is recalling 16 cases of CMS-2890 Custom Needle Local Trays because the manufacturer lacked microbial testing and the product did not meet finished goods specifications.
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 medical device where the manufacturer lacked microbial testing and the product failed to meet specifications, representing a risk of harm (infection) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Custom Medical Specialties, Inc. is recalling 16 cases of CMS-2890 Custom Needle Local Trays containing PVP Prep Pads. The product is used for skin preparation in medical procedures. The recall was initiated after the firm observed a manufacturer recall on the FDA website citing the absence of microbial testing and failure to meet proper finished goods specifications.
The affected products were distributed nationwide, including in Georgia, Michigan, New York, and Pennsylvania. The specific lot codes involved are 16480-0908, 20976-1008, and 21283-1009. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers should check their inventory for these specific lot codes and stop using the affected trays. The source text does not provide specific instructions for disposal or return, but standard recall procedures typically involve contacting the manufacturer or the FDA for further guidance.
The recalled product
- Product
- CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
- Manufacturer
- Custom Medical Specialties, Inc.
- Affected units
- 16
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 (3)
- 16480-0908
- 20976-1008
- 21283-1009
Distribution
Part of a larger recall action
This product is one of 4 recalled by Custom Medical Specialties, 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.
See all 4 products in this recall →Related recalls
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