Device recall: Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.

FDA enforcement event 64908 · Class III · initiated 12 Apr 2013 · status Terminated · terminated 2 Jun 2015

DeviceVoluntary: Firm initiated2 product recordsMansfield, MA

Covidien LLC (Mansfield, MA) initiated this device recall on 12 Apr 2013; FDA lists 2 product records under event 64908, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 2 Jun 2015. Initiation: voluntary: firm initiated. Covidien LLC has 77 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

Covidien LLC, Mansfield, MA.

Reason for recall

"On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits."

Distribution

"Worldwide distribution: USA (nationwide) and in the country of: Panama."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1303-2013	Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit.	17740 kits	Class III	Terminated	22 May 2013
Z-1304-2013	Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit.	52363 distributed	Class III	Terminated	22 May 2013

Context

5%of 2013 device events are Class III1,236 events that year

2product records in this eventfirm median: 1

77events on this register for the firm

Other enforcement events for Covidien LLC

Initiated	Product (first record)	Type	Class	Records
13 May 2026	EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOF	Device	Class II	1
23 Apr 2026	Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042	Device	Class II	3
23 Apr 2026	Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidi	Device	Class II	1
15 Apr 2026	COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intende	Device	Class II	1
30 Jan 2026	HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 M	Device	Class II	1
25 Apr 2024	EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only	Device	Class II	1
2 Jun 2023	Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-US	Device	Class II	1
22 May 2023	Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS	Device	Class II	1
23 Nov 2022	COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1	Device	Class II	1
19 Aug 2022	Puritan Bennett 560 Ventilator, PB560, CFN 4096600	Device	Class II	1

All 77 events for Covidien LLC

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide distribution: USA (nationwide) and in the country of: Panama."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 2 Jun 2015. "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.