Custom Healthcare Systems Recalls Mosquito Forceps Kits Due to Sterility Compromise
Custom Healthcare Systems is recalling 50 units of Mosquito Forceps 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 harm (infection) even though specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling 50 units of CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR (Product Number: B9-18914). 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 lot number is 51418, with an expiration date of 5/1/2021. The 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 classifies this as a Class II recall. Healthcare providers and consumers should stop using these specific kits and contact the manufacturer for further instructions or replacement.
The recalled product
- Product
- CHS Custom Convenience Kit-MOSQUITO FORCEPS 5 STR Product Number:B9-18914
- Manufacturer
- Custom Healthcare Systems, Inc.
- Affected units
- 50
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.
See all 29 products in this recall →Related recalls
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