CHS Custom Convenience Kits Recalled for Sterility Compromise
Custom Healthcare Systems is recalling 630 CHS Custom Convenience 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 infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 630 units of the CHS Custom Convenience Kit-GENERAL UTILITY TRAY (Product Number: S1528-02). 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 have Lot number 70618 and an expiration date of 1/1/2021. The units were distributed to facilities in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
Consumers and healthcare facilities should stop using the affected products immediately and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- CHS Custom Convenience Kit-GENERAL UTILITY TRAY Product Number:S1528-02
- Manufacturer
- Custom Healthcare Systems, Inc.
- Affected units
- 630
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: 70618 Exp. Date:1/1/2021
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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