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MEDRAD Avanta Fluid Management Injection System, Catalog… recallZ-2866-2011 · Medrad Inc · initiated Jun 2, 2011

Terminated All recalls posted in July 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medrad Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complaints and adverse event reporting resulted in the firm issuing "Important Product Use Reminder" to remind users of proper procedures for using the system and the need for diligence in reducing air embo

FDA root cause category: Device Design

What the company is doing

Medrad Inc., sent two types of "MEDICAL DEVICE FIELD CORRECTION" notifications on June 2, 2011 to all affected customers. 1. To those customers who Avanta Systems have already undergone market withdrawal and thus have been upgraded, the notification provided customer awareness that prior action should be considered a field correction. The letter stated that NO action is required since their system(s) has already been upgraded. If you have any questions, concerning these activities contact the Director of Quality Systems at (724) 940-6905. 2. To those customers whose Avanta Systems have not yet been upgraded through market withdrawal, the notification informed customers that the recalling firm is undertaking a Field Correction to upgrade their system(s). The letter included a step by step guide that will allow customers to verify that their system(s) has NOT been upgraded. Customers are instructed to complete and fax this form to MEDRAD at (412) 406-0941. If you have any questions, concerning these activities contact the Product Manager at (412) 767-2400, extension 8401.

Recall details

Recall number
Z-2866-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 2, 2011
Posted by the FDA
Jul 22, 2011
Recalling firm
Medrad Inc
Quantity
842
Product code
DXT
FDA submissions
K050456
Distribution
Worldwide Distribution -- (USA) (nationwide) including the state of Puerto Ricoand the countries of: AE, AL, AT, BE, BG, BR, CA, CH, CO, CY, DE, DK, DO, ES, FI, FR, GB, HK, HR, HU, IE, IL, IS, IT, JO, JP, KR, KW, LY, MA, MT, MX, MY, NL, PA, PH, PK, PT, QA, RS, RU, SA, SE, SG, SI, TR, VI, and ZA.

Product description

MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions during angiographic procedures.

Code information (models, lots, serial numbers)

Catalog numbers: AVA 500 TABL, AVA 500 PEDL

Other devices under the same FDA submission

3 devices cleared under K050456 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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