Custom Healthcare Systems Recalls Convenience Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling specific lots of 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 is classified as FDA Class II, and the hazard involves compromised sterility of medical devices, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling specific lots of CHS Custom Convenience Kits. The affected products include the DT SCATPAD, DBL. TAPE, 12.5 X 16.5 (Product Number: SEPA 402) and the SCATPAD, 11 X 34 (Product Number: SPA502). The recall involves 750 units of the first product and 200 units of the second product.
The recall was initiated because the convenience kits were sealed in immediate Tyvek pouches using incorrect specifications, which compromised the sterility of the products. The affected lots are identified as Lot Number 72018 and Lot Number 71118, both with an expiration date of July 1, 2021.
The products were distributed to facilities in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina. Consumers and healthcare providers should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Wound Care
- Hazard
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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