MedComp Recalls Split Cath III Trays Due to Incorrect Length Labeling
Medical Components, Inc. is recalling 110 Split Cath III Trays because they were incorrectly labeled as 32CM instead of 28CM.
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 hazard is a minor labeling error regarding product dimensions without reported injuries or illnesses.
Plain-English summary
Medical Components, Inc. dba MedComp is recalling 110 units of Split Cath III Trays, 16F x 28CM. The product is indicated for use in attaining long-term vascular access for hemodialysis and apheresis in adult patients.
The recall was initiated because the trays were incorrectly labeled as 16F x 32CM Split Cath III instead of the correct 28CM length. The affected units are identified by Tray #55216-3 and specific lot numbers with expiration dates ranging from October 2016 to January 2017.
The products were distributed nationwide in the United States. Consumers and healthcare providers should stop using the affected trays and contact the recalling firm for further instructions.
The recalled product
- Product
- Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients.
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Vascular Access
- Hazard
- Affected units
- 110
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 (9)
- TRAY #55216-3
- Lot numbers: MBTX960
- exp. 10/2016
- MBVA850
- MBVD080
- exp. 01/2017
- MBVG680
- MBVL020
- exp. 01/2017.
Distribution
Distributed nationwide across the United States.
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