Custom Healthcare Systems Recalls Suture Removal Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 1,250 suture removal 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. The hazard involves compromised sterility of a medical device, which presents a risk of infection (harm) even though specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 1,250 units of the CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR), Product Number UNC-9481B. 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 lots have expiration dates of 5/1/2021 and 2/1/2021, with lot number 51018. The products were distributed to facilities in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
Healthcare facilities should stop using the affected suture removal kits and contact Custom Healthcare Systems for instructions on return or disposal. Consumers who have purchased these specific medical kits should contact their healthcare provider or the manufacturer for guidance.
The recalled product
- Product
- CHS Custom Convenience Kit-SUTURE REMOVAL KIT (W.ADSON SERR)Product Number:UNC-9481B
- Manufacturer
- Custom Healthcare Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,250
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:51018 Exp Date: 5/1/2021 Exp. Date: 2/1/2021
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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