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Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B… recallZ-1198-2021 · Medtronic Perfusion Systems · initiated Feb 4, 2021

Terminated

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 Medtronic Perfusion Systems 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

Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response.

FDA root cause category: Device Design

What the company is doing

A written Medical Device Correction letter will be mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete the enclosed Customer Confirmation Form and email to [email protected]. Consignees will also be asked to return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at800-854-3570 to initiate a product return.

Recall details

Recall number
Z-1198-2021
Status
Terminated
Initiated by the company
Feb 4, 2021
Posted by the FDA
Mar 17, 2021
Recalling firm
Medtronic Perfusion Systems
Quantity
4 units
Product code
DTN
FDA submissions
K183511
Distribution
Worldwide distribution: US nationwide, Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam

Product description

Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).

Code information (models, lots, serial numbers)

Description: PERFUSION M484901D 1/B. Model Number: M484901D. GTIN: 00763000240288. Lot Number: 220906731.

Other devices under the same FDA submission

2 devices cleared under K183511 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 87271).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page