Medcomp Titan HD Catheter Kits Recalled for Incorrect Valve Size
Medical Components, Inc. is recalling 132 Medcomp Titan HD catheter kits because they were packaged with a 15F valve instead of the correct 16F valve.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a packaging error involving the wrong size valve, which is a moderate risk.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 132 units of Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024. The recall is due to a packaging error where the kits were supplied with an incorrect size valve peelable introducer.
The affected kits contain a 15F valve peelable introducer instead of the correct 16F valve. The specific lot number is MPCT670, with a UDI of 884908129304 and an expiration date of 12/20/2020. The products were distributed to Arizona, California, Florida, Georgia, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Virginia, and Washington.
Healthcare providers and consumers should check their inventory for this specific product reference and lot number. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Catheters
- Affected units
- 132
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)
- Lot # MPCT670
- UDI 884908129304 Exp. Date 12/20/2020
Distribution
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