Anorectal manometry kit outer label shows the manufacturing date as expiry
Zvu Anorectal Manometry Procedure Kits are being recalled because the outer kit label carries an incorrect expiration date, with the manufacturing date used in its place. 8 kits are affected.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall over an incorrect expiry date on the outer label only, with the component labels inside showing the correct date.
Plain-English summary
The Zvu Anorectal Manometry Procedure Kit, REF HRAM-PROC-10, UDI-DI 00816734022863, is being recalled. The action covers 8 units from lot 24752.
The stated reason is that the outer kit label is mislabelled with an incorrect expiration date, with the manufacturing date used in place of the expiration date. All inner labels on the kit components display the correct expiration date. The FDA classified the action as Class III, its least serious classification.
Distribution was worldwide, including nationwide in the United States in New Mexico, Massachusetts, Colorado and Ohio, and to other countries.
Facilities should identify affected stock using the REF, UDI-DI and lot number above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
- Manufacturer
- Diversatek Healthcare
- Category
- Medical Device — Procedure kit
- Affected units
- 8
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)
- UDI-DI: 00816734022863
- Lot: 24752
Distribution
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