Custom Healthcare Systems Recalls Bone Marrow Tray Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 48 units of Bone Marrow Tray Convenience Kits because incorrect sealing specifications compromised product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 48 units of CHS Custom Convenience Kit-BONE MARROW TRAY (Product Number: B9-4000). 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 are identified by Lot number 61518 and have an expiration date of 12/1/2020. These products were distributed to facilities in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
The U.S. Food and Drug Administration has classified this recall as Class II. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 48
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: 61518 Exp Date: 12/1/2020
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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