Custom Healthcare Systems Recalls Toothbrush Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 100 units of toothbrush kits because incorrect sealing specifications compromised product sterility.
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 sterility was compromised, creating a risk of harm (infection) even though no specific injuries are reported in the source text, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 100 units of CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT (Product Number: R1635). The recall affects lot number 51418 with an expiration date of 5/1/2021.
The recall was initiated because the convenience kits were sealed in immediate Tyvek pouches using incorrect specifications, which compromised the sterility of the product. The affected units were distributed in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
Consumers who have this product should stop using it and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- CHS Custom Convenience Kit-TOOTHBRUSH, 46 TUFT Product Number:R1635
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Dental
- Affected units
- 100
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 number: 51418 Exp. Date: 5/1/2021
Distribution
Part of a larger recall action
This product is one of 29 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.
See all 29 products in this recall →Related recalls
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