Dover recallZ-0360-2023 · Cardinal Health · initiated Nov 1, 2022

Why it was recalled

Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

FDA root cause category: Equipment maintenance

What the company is doing

Cardinal Health issued Urgent Medical Device Recall Letter (Event-2022-04944) and Acknowledgement Form on November 1, 2022 to the direct consignees. Letter states reason for recall, health risk and action to take: Actions Required: 1. REVIEW your inventory for the affected product codes and lots. Location of product codes and lots are shown in Attachment 1. 2. SEGREGATE and quarantine all affected product upon review of your inventory. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product to or will send the product on to about this product recall notice and share a copy of this notice. 4. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to [email protected], whether you have affected product. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5pm EST: " Hospital 800-965-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All Other Customers 888-444-5440 For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.

Recall details

Recall number

Z-0360-2023

Status

Open, Classified

Initiated by the company

Nov 1, 2022

Posted by the FDA

Dec 2, 2022

Recalling firm

Cardinal Health

Product code

FCM

FDA submissions

K903340

Distribution

Nationwide

Product description

Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient

Devices named in this recall

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

• Dover 3450

  Cardinal Health, Inc. · Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
  1 recall1 report

Product lines

• DoverCardinal Health, Inc. · 90 models · 226 reports · 12 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 91087).

• Z-0356-2023 · Open, Classified
  Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
• Z-0357-2023 · Open, Classified
  Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
• Z-0358-2023 · Open, Classified
  Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
• Z-0359-2023 · Open, Classified
  Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
• Z-0361-2023 · Open, Classified
  Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the b…