Device recall: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary dr

FDA enforcement event 91087 · Class II · initiated 1 Nov 2022 · status Ongoing

DeviceVoluntary: Firm initiated6 product recordsMansfield, MA

Cardinal Health (Mansfield, MA) initiated this device recall on 1 Nov 2022; FDA lists 6 product records under event 91087, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Cardinal Health has 12 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Cardinal Health, Mansfield, MA.

Reason for recall

"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"

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0356-2023	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	N/A	Class II	Ongoing	14 Dec 2022
Z-0357-2023	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	N/A	Class II	Ongoing	14 Dec 2022
Z-0358-2023	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	N/A	Class II	Ongoing	14 Dec 2022
Z-0359-2023	Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient	N/A	Class II	Ongoing	14 Dec 2022
Z-0360-2023	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	N/A	Class II	Ongoing	14 Dec 2022
Z-0361-2023	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 bladder of a patient.	N/A	Class II	Ongoing	14 Dec 2022

Context

88%of 2022 device events are Class II839 events that year

6product records in this eventfirm median: 1

12events on this register for the firm

Other enforcement events for Cardinal Health

Initiated	Product (first record)	Type	Class	Records
2 Nov 2021	SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474	Device	Class II	11
4 Aug 2021	Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicat	Device	Class I	3
11 Jan 2020	AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA	Device	Class II	39
20 Jul 2016	BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Ste	Device	Class II	1
27 Jun 2016	The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Me	Device	Class II	1
29 Feb 2016	Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of	Device	Class II	1
25 Aug 2015	Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for m	Device	Class II	1
23 Dec 2014	Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is us	Device	Class II	1
2 Oct 2013	Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated ship	Drug	Class III	1
18 Dec 2012	Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat.	Device	Class II	9

All 12 events for Cardinal Health

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.