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Magic3 Go Pediatric Catheter with SureGrip recallZ-1700-2023 · C.R. Bard Inc · initiated Apr 20, 2023

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 C.R. Bard 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

Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

FDA root cause category: Under Investigation by firm

What the company is doing

The firm issued an URGENT MEDICAL DEVICE RECALL to its consignee beginning on 04/20/2023 by Fed Ex and email. The notice explained the problem, risk, and requested the following actions be taken: Discontinue distribution of the product and dispose of all affected product, Distributors are directed to notify their customers. For further assistance please contact: 1-844-8BD- LIFE (1-844-823-5433) Say "Recall" when prompted; M-F 8am - 5pm CT

Recall details

Recall number
Z-1700-2023
Status
Open, Classified
Initiated by the company
Apr 20, 2023
Posted by the FDA
Jun 8, 2023
Recalling firm
C.R. Bard Inc
Quantity
5760 devices
Product code
EZD
FDA submissions
K172247
Distribution
Worldwide

Product description

Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G

Code information (models, lots, serial numbers)

a) REF 52810G, UDI/DI 00801741136870, Lot Numbers: JUGW1445

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92082).

Sources and updates

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