Custom Healthcare Systems Recalls Sterility-Compromised Connector Packs
Custom Healthcare Systems is recalling 150 units of CHS Custom Convenience Kit-CONNECTOR PACK due to incorrect sealing specifications that 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 with compromised sterility, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 150 units of the CHS Custom Convenience Kit-CONNECTOR PACK, Product Number D36-7520. The recall is due to convenience kits being sealed in immediate Tyvek pouches using incorrect specifications, which compromised the product's sterility.
The affected lot number is 51418, with an expiration date of 5/1/2021. The products were distributed to facilities 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 Custom Healthcare Systems, Inc. for further instructions or a return.
The recalled product
- Product
- CHS Custom Convenience Kit-CONNECTOR PACK Product Number:D36-7520
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Surgical Kits
- 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: 51418 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.
See all 29 products in this recall →Related recalls
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