Custom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 60 units of CHS Custom Convenience Kits because incorrect sealing specifications compromised product sterility.
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 compromised sterility, which poses a risk of harm (infection) to patients, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 60 units of CHS Custom Convenience Kit-TUBING W. CONNECTOR (Product Number: UNC-10884). The recall was initiated because the convenience kits were sealed in immediate Tyvek pouches using incorrect specifications, which compromised the product sterility.
The affected products are identified by Lot number 52418 and have an expiration date of 5/1/2021. The products were distributed to locations in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- CHS Custom Convenience Kit-TUBING W. CONNECTOR Product Number:UNC-10884
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 60
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:52418 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.
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