Device recall: Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated

FDA enforcement event 70985 · Class II · initiated 23 Apr 2015 · status Terminated · terminated 26 Jul 2017

DeviceVoluntary: Firm initiated62 product recordsNorth Haven, CT

Covidien LLC (North Haven, CT) initiated this device recall on 23 Apr 2015; FDA lists 62 product records under event 70985, 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 26 Jul 2017. 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, North Haven, CT.

Reason for recall

"Catheters may not meet antimicrobial specification"

Distribution

"Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1850-2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion.	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1851-2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 23cm Item Code: 8888245063	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1852-2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1853-2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1854-2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1857-2015	Palindrome SI Chronic Catheter Sport Pack 14.5 Fr x 33 cm Item Code: 8888233508	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1858-2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1859-2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062C	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1860-2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1861-2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063C	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1862-2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1863-2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1864-2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1865-2015	Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065C	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1866-2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1867-2015	Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1868-2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1869-2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145062CP	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1870-2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1871-2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145063CP	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1872-2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1873-2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064CP	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1874-2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1875-2015	Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cmItem Code: 8888145065CP	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1876-2015	Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1877-2015	Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1878-2015	Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1879-2015	Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1880-2015	Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1881-2015	Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1882-2015	Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1883-2015	Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1884-2015	Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119368P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1885-2015	Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123408P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1886-2015	Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1887-2015	Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1888-2015	Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1889-2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057C	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1890-2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145048	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1891-2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048C	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1892-2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1893-2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1894-2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1895-2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1896-2015	Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1897-2015	Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1898-2015	Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1899-2015	Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048CP	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1900-2015	Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1901-2015	Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145049CP	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1902-2015	Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1903-2015	Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050CP	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1904-2015	Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1905-2015	Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1906-2015	Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1907-2015	Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1908-2015	Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1909-2015	Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888123409P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1910-2015	Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128459P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015
Z-1911-2015	Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P	72,363 US - 24,631 Internationally	Class II	Terminated	8 Jul 2015

Showing 60 of 62 product records; the FDA enforcement report lists all of them.

Context

91%of 2015 device events are Class II1,153 events that year

62product 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: "Catheters may not meet antimicrobial specification"

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: "Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 26 Jul 2017. "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.