Custom Healthcare Systems Recalls 250 LP Needle Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 250 units of 22G LP Needle 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 involves a medical device where sterility was compromised, creating a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 250 units of CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 (Product Number: NC401000). The affected lot number is 51018, 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 product's sterility. The product was distributed in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
Consumers who have this product should stop using it and contact Custom Healthcare Systems, Inc. for further instructions.
The recalled product
- Product
- CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
- Manufacturer
- Custom Healthcare Systems, Inc.
- Affected units
- 250
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: 51018 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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