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Open, Classified

Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

FDA Recall Z-0484-2024 · Posted 2023-12-02

Recalling FirmAtrium Medical Corporation
Recall StatusOpen, Classified
Product CodeGBZ
Date Initiated2023-09-29
Product Quantity2460 units (246 cases, 10 units/case)

Reason for Recall

A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.

Firm Action

An Urgent Medical Device - Removal notice was sent via Fed-Ex on October 25, 2023. The letter advises customers to check for and remove from inventory Atrium Firm PVC Catheter 36 FR Straight, part number 15036, lot ME234686. Forward this information to all current and potential Atrium Firm PVC Thoracic Catheter 36FR Straight users within your hospital / facility, or to any customer product was further distributed to. Contact your local Atrium/Getinge Customer Service department at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)to request a return authorization (RMA) and shipping instructions to return any affected product.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX

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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