Custom Healthcare Systems Recalls Cast Padding Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 30 units of cast padding 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 the hazard involves compromised sterility of a medical device, which poses a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 30 units of CHS Custom Convenience Kit-SPECIALIST CAST PADDING (3" x 4 yds), Product Number D4-324SCP. The recall involves Lot 51418 with an expiration date of 5/1/2021.
The recall was initiated because the convenience kits were sealed in immediate Tyvek pouches using incorrect specifications, which compromised the sterility of the product. The affected units were distributed in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
Consumers and healthcare facilities should stop using the affected product and contact Custom Healthcare Systems, Inc. for further instructions or a return.
The recalled product
- Product
- CHS Custom Convenience Kit-SPECIALIST¿ CAST PADDING 3" X 4 YDS) Product Number:D4-324SCP
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Cast Padding
- Affected units
- 30
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.
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