Atrium 36Fr Right Angled Firm PVC Thoracic Catheter Recall
Atrium Medical Corporation is recalling 620 units of 36Fr Right Angled Firm PVC Thoracic Catheters due to incorrect labeling on inner pouches.
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: This is a Class II recall involving a labeling error that could lead to the use of the wrong medical device, but no injuries or illnesses have been reported.
Plain-English summary
Atrium Medical Corporation is recalling 620 units of Atrium 36Fr Right Angled Firm PVC Thoracic Catheters (Part Number 15236). The recall involves 62 cases, with 10 units per case. The affected units are from Lot Number ME215673, with an expiration date of 09/2019.
The recall was initiated because the inner pouches were incorrectly labeled. The pouches were labeled as part 8136, which corresponds to a 36Fr Right Angled Thermosensitive PVC catheter, but the actual product inside is the 36Fr Right Angled Firm PVC Catheter (Part Number 15236). This labeling error could lead to the use of the wrong catheter type during medical procedures.
The affected units were distributed to facilities in Arizona, California, Louisiana, Indiana, North Carolina, Tennessee, Texas, and Virginia. Healthcare facilities should stop using the affected units and contact Atrium Medical Corporation for further instructions.
The recalled product
- Product
- Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Catheter
- Hazard
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 (1)
- Lot Number : ME215673 EXp: 2019/09
Distribution
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