Diversatek M-Catch Retrieval Nets: incorrect inner polybag labeling
Diversatek Healthcare is recalling M-Catch Retrieval Nets (Part Number REF 1175-01, Lot Number 001919) due to incorrect inner polybag labeling. 245 devices were distributed nationwide between September and October 2021.
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 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 II recall for a minor labeling error (incorrect inner polybag labeling) with no reported illnesses or injuries. Per the severity rubric, minor labeling errors without reported harm are classified as Moderate (2).
Plain-English summary
Diversatek Healthcare is recalling M-Catch Retrieval Nets, Part Number REF 1175-01, Lot Number 001919. These devices are used endoscopically to retrieve severed polyps, tissue samples, food bolus, and foreign bodies from the gastrointestinal tract. The recalled devices contain incorrect labeling on the inner polybag; the outer package labeling is correct.
A total of 245 devices were distributed nationwide between September 27, 2021, and October 22, 2021. The affected devices are identified by UDI/DI 00816734021361.
The recalled product
- Product
- Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.
- Manufacturer
- Diversatek Healthcare
- Hazard
- Affected units
- 245
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 (4)
- UDI/DI 00816734021361
- lot number 001919
- 2024-10-31
- shipped between 9-27-2021 and 10-22-2021.
Distribution
Distributed nationwide across the United States.
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