CHS Cotton Tip Applicators Recalled Due to Sterility Compromise
Custom Healthcare Systems is recalling 150 units of CHS Cotton Tip Applicators because incorrect sealing specifications compromised product sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) according to the rubric, as it involves a product defect that could cause temporary or medically reversible health consequences.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 150 units of CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") (Product Number: R1112B). The recall involves Lot number 52418 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. This is classified as an FDA Class II recall.
The affected products were distributed 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 manufacturer for further instructions.
The recalled product
- Product
- CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
- Manufacturer
- Custom Healthcare Systems, Inc.
- Hazard
- Affected units
- 150
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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