Custom Healthcare Systems Recalls Toenail Removal Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 80 units of Toenail Removal 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 is classified as FDA Class II, and the hazard involves compromised sterility in a medical device, which poses a risk of harm even without reported injuries.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 80 units of CHS Custom Convenience Kit-Toenail Removal Tray, product numbers ZZ-0956 and ZZ-0685. The recall is due to the convenience kits being sealed in immediate Tyvek pouches using incorrect specifications, which compromised the product's sterility.
The affected products are distributed in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina. The specific lot numbers are 71718 and 70618, both with an expiration date of July 1, 2021.
Consumers and healthcare facilities should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Surgical Kits
- 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)
- Lot number: (1) 71718 Exp. Date: 7/1/2021 (2) 70618 Exp Date: 7/1/2021
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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