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Terminated

Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236

FDA Recall Z-2346-2015 · Posted 2015-08-05

Recalling FirmAtrium Medical Corporation
Recall StatusTerminated
Product CodeGBZ
Date Initiated2015-06-19
Date Terminated2016-03-21
Product Quantity62 cases (10/cs)=620 units

Reason for Recall

Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter

Firm Action

Atrium Medical notified accounts by letter dated 6/18/15, explaining the mislabeled inner units. If any product is discovered with incorrect labeling, the product may be used or product may be returned for credit. contact your local Atrium/Maquet chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).

Root Cause

Employee error

Distribution Pattern

AZ, CA, LA. IN, NC, TN, TX, VA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K831931ATRIUM THORACIC CATHETERAtrium Medical Corp. · 1983-10-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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