Custom Healthcare Systems Recalls Non-Sterile Convenience Gowns
Custom Healthcare Systems is recalling 72,832 units of convenience gowns because they were sealed with incorrect specifications, compromising 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 is classified as FDA Class II, and the hazard involves compromised sterility in a medical device, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 72,832 units of CHS Custom Convenience gowns, including Raglan and Specialty XL models. The recall involves specific lot numbers W72318, W72118, and W71818, with an expiration date of July 1, 2021. The products were distributed to facilities in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
The recall was initiated because the convenience kits were sealed in immediate Tyvek pouches using incorrect specifications. This error compromised the product sterility, meaning the gowns may not be sterile as intended for medical use.
Healthcare facilities and consumers who have these specific gowns should stop using them immediately. Users should contact Custom Healthcare Systems, Inc. for instructions on how to return the affected products.
The recalled product
- Product
- CHS Custom Convenience (1) 1231-150L GOWN, RAGLAN, LG, NONREINF (2) 1231-150XL GOWN, RAGLAN, XL, NONREINF (3) 1231-140XL GOWN, SPECIALTY XL, XLONG
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Surgical Gowns
- Affected units
- 72,832
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 (9)
- (1)1231-150L GOWN
- RAGLAN
- LG
- NONREINF Lot Numbers: W72318
- W72118 (2) 1231-150XL GOWN
- XL
- NONREINF Lot Number: W72318 (3) 1231-140XL GOWN
- SPECIALTY XL
- XLONG Lot Number: W71818 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.
See all 29 products in this recall →Related recalls
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