Catheter Research Recalls Mislabeled HSG Trays and Catheters
Catheter Research, Inc. is recalling 880 HSG trays and catheters because the flexible and shapeable catheters were mislabeled on the packaging.
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: The recall is classified as FDA Class II, and the source text describes a labeling error without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk issues where harm has not been reported.
Plain-English summary
Catheter Research, Inc. is recalling 880 units of HSG Trays/HS 5F Catheter Combo and HSG Procedure Tray+ Shapeable 5F HSG catheter. These medical devices are used for hysterosonography and hysterosalpingography procedures for gynecological use.
The recall was initiated because the products were mislabeled. Trays containing the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa. This labeling error could lead to the use of the wrong catheter type during a procedure.
The affected products were distributed domestically in Minnesota, California, Ohio, Illinois, Florida, Massachusetts, Wisconsin, and Virginia. No foreign distribution or distribution to DOD/VA facilities is reported. Consumers and healthcare providers should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
- Manufacturer
- Catheter Research, Inc
- Hazard
- Affected units
- 880
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 (15)
- Model Number/Catalogue/Product Number: TMI1160
- 61-5205
- TMI1198
- KM61-5205
- 61-3205
- Lot codes: J436A
- J436B
- J436C
- J436D
- J437A
- J437B
- J437C
- J437D
- Exp. J436 (2017-03)
- J437 (2017-03)
Distribution
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