Custom Healthcare Systems Recalls Surgical Gowns Due to Sterility Compromise
Custom Healthcare Systems is recalling 89 units of surgical gowns and 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 or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 89 units of CHS Custom Convenience Kits, which include surgical gowns and hand towels. The recall involves specific lot numbers W72118 with an expiration date of July 1, 2021.
The recall was initiated because the convenience kits were sealed in immediate Tyvek pouches using incorrect specifications. This error compromised the sterility of the products. The affected units were distributed to facilities in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
Healthcare facilities and consumers should stop using these products immediately. The source text does not specify a particular action for disposal or return, but users should verify their inventory against the provided lot and expiration details.
The recalled product
- Product
- CHS Custom Convenience Kit: 1231-110XL SURGICAL GOWN, NRF W. HAND TOWEL 1231-080XL GOWN, SURGICAL XXL 1231-150XL GOWN, SURGICAL XXL
- Manufacturer
- Custom Healthcare Systems, Inc.
- Affected units
- 89
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: :W72118 Exp Date:7/1/2021
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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