Custom Healthcare Systems Webster Needle Holder Kits Recalled for Sterility Compromise
Custom Healthcare Systems is recalling Webster Needle Holder 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 infection (risk-of-harm product). No specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 72 units of CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER (Product Number: 01-375C). The recall affects Lot number 61918 with an expiration date of 6/1/2021.
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 defect poses a risk of infection if the non-sterile instruments are used in a surgical or medical setting.
The affected products were distributed to facilities in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina. Users should stop using the affected kits immediately and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C
- Manufacturer
- Custom Healthcare Systems, Inc.
- Affected units
- 72
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: 61918 Exp. Date: 6/1/2021
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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