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Drager SafeStar 55, Catalog No. MP01790 recallZ-1211-2022 · Draeger Medical, Inc. · initiated May 16, 2022

Open, Classified

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 Draeger Medical, 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

Possible occlusion of filters due to manufacturing error.

FDA root cause category: Process design

What the company is doing

The firm distributed a notification titled "URGENT MEDICAL DEVICE RECALL" by mail on 05/16/2022, in which it informed customers of the voluntary recall of Lot LT2103 of Draeger SafeStar 55 Breathing System Filters, Ref. No. MP01790, UDI-DI 04048675026785. The firm states that this recall is being initiated in response to becoming aware of a complaint in which a patient became hypoxic and had to be resuscitated while under anesthesia using the Draeger SafeStar 55 Breathing System Filter from the affected lot. The firm indicated that a manufacturing feature that automatically destroys filters that fail acceptance testing was disabled during servicing, which resulted in filters having to be hand sorted during manufacturing of Lot LT2103. Drager is asking customers to check their inventory for SafeStar 55 breathing system filters from Lot LT2103. If any affected product is on hand, customers are to call Draeger Customer Service at 1-80-437-2437, fax at 1-215-723-5935, or email at US-Medical@draeger to obtain free replacement of product. If any affected product is on hand, customers are to segregate and quarantine product until Draeger's provision of a return materials authorization and pre-paid shipping labels. Draeger also asks customers to make the recall notification available within their organization and to forward a copy if product was further distributed. A Customer Acknowledgement Form was provided with the notification for all customers to complete and return. Customers with any questions are to contact Michael Kelhart, Quality Director, between the hours of 8:00 AM and 4:30 PM EST at 1-800-437-2437, press 1, then 32349.

Recall details

Recall number
Z-1211-2022
Status
Open, Classified
Initiated by the company
May 16, 2022
Recalling firm
Draeger Medical, Inc.
Quantity
35,950
Product code
CAH
FDA submissions
K072002
Distribution
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, NC, ND, NV, NY, OH, PA, TN, TX, WA, and WV. The countries of Austria, Belgium, Bulgaria, Canada, Columbia, Croatia, Czech Republic, Denmark, France, Germany, India, Indonesia, Ireland, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Malaysia, Morocco, Netherlands, Norway, Philippines, Portugal, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Spain, Suriname, Sweden, Switzerland, Thailand, United Kingdom, and United Arab Emirates.

Product description

Drager SafeStar 55, Catalog No. MP01790

Code information (models, lots, serial numbers)

UDI-DI: 04048675026785; Lot No. LT2103.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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