Custom Healthcare Systems Recalls Surgical Gown Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 7,200 surgical gown 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 is classified as FDA Class II and involves a risk-of-harm product (sterility compromise) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 7,200 units of CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES (Product Number: 1231-050L). The recall involves lot numbers W72018 and W71218, which have an expiration date of July 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 is classified as an FDA Class II recall.
The affected products were distributed in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina. Users should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- CHS Custom Convenience Kit-SURGICAL GOWN, LARGE SET IN SLEEVES Product Number:1231-050L
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Surgical Gowns
- Affected units
- 7,200
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 (2)
- Lot numbers: W72018
- W71218 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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