Severity
Moderate
FDA Devices recall · Reported August 12, 2015
Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
Atrium Medical Corporation recalled Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236 - a moderate-severity action.
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236 was recalled by Atrium Medical Corporation in August 12, 2015. Reason: Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part …. Check the official notice for the remedy. Verify recall #Z-2346-2015 with the FDA Devices before acting.
The recall
Atrium Medical Corporation issued this moderate-severity FDA Devices recall-Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part ….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2346-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2346-2015) was formally reported on August 12, 2015, with the manufacturer initiating the action on June 19, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Atrium Medical Corporation is listed as the recalling firm, operating out of Hudson, NH. Federal records list the affected scope as 62 cases (10/cs)=620 units.
The documented reason for this recall is: Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter Distribution data in the federal record shows the product reached: AZ, CA, LA. IN, NC, TN, TX, VA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
62 cases (10/cs)=620 units
Related Recalls
6
3 from same agency
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2346-2015 |
| Date reported | August 12, 2015 |
| Date initiated | June 19, 2015 |
| Recalling firm | Atrium Medical Corporation |
| Firm location | Hudson, NH |
| Affected scope | 62 cases (10/cs)=620 units |
| Distribution | AZ, CA, LA. IN, NC, TN, TX, VA |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 12, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.