Custom Healthcare Systems Recalls Vaginal Speculums Due to Sterility Compromise
Custom Healthcare Systems is recalling vaginal speculums 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 the hazard involves compromised sterility of a medical device, which poses a risk of harm (infection) even if specific injuries are not yet reported in the text.
Plain-English summary
Custom Healthcare Systems, Inc. is recalling two types of CHS Custom Convenience Kits containing vaginal speculums (small and large). The recall involves 180 units of each product type. The affected products were distributed in Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, and South Carolina.
The recall was initiated because the convenience kits were sealed in immediate Tyvek pouches using incorrect specifications. This error compromised the sterility of the products. The agency has classified this as a Class II recall.
Healthcare providers and consumers should stop using the affected products immediately. The specific lot numbers and expiration dates for the recalled items are provided in the structured product information. Users should contact the manufacturer for further instructions on disposal or replacement.
The recalled product
- Product
- (1)CHS Custom Convenience Kit-VAGINAL SPECULUM (SMALL) Product Number:D36-16267 (2) CHS Custom Convenience KitVAGINAL SPECULUM (LARGE) Product Code: D36-16269
- Manufacturer
- Custom Healthcare Systems, Inc.
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)
- (1)Lot number: 52418
- 51418 Exp. Date: 5/1/2021 (2) 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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