Device recall: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP

Class I FDA enforcement event 92660. Recall start date: 28 Jun 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow,…

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Covidien LP started this device recall on 28 Jun 2023. The firm address in the FDA record is in Mansfield, MA. FDA put the recall in Class I. FDA event 92660 has 25 product records. The first FDA enforcement report date is 23 Aug 2023. The record gives the status Ongoing.

FDA enforcement report The 25 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide - Worldwide Distribution Foreign: Argentina Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Canada Cayman Islands China Costa Rica Czech Republic Denmark Dominican Republic…

Recalling firm

Covidien LP, Mansfield, MA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

25 product records in the event.

FDA event 92660: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2367-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP	2370 units	Class I	Ongoing	23 Aug 2023
Z-2368-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, IC Tray REF: 8888101002HP	6615	Class I	Ongoing	23 Aug 2023
Z-2369-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, IC Tray REF: 8888101003HP	5373 units	Class I	Ongoing	23 Aug 2023
Z-2370-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, IC Tray REF: 8888101004HP	1325 units	Class I	Ongoing	23 Aug 2023
Z-2371-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP	1875 units	Class I	Ongoing	23 Aug 2023
Z-2372-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP	685 units	Class I	Ongoing	23 Aug 2023
Z-2373-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, PASS Tray REF: 8888103001HP	299 units	Class I	Ongoing	23 Aug 2023
Z-2374-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP	299 units	Class I	Ongoing	23 Aug 2023
Z-2375-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, PASS Tray REF: 8888103004HP	271 units	Class I	Ongoing	23 Aug 2023
Z-2376-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, PASS Tray REF: 8888104003HP	1099 units	Class I	Ongoing	23 Aug 2023
Z-2377-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP	519 units	Class I	Ongoing	23 Aug 2023
Z-2378-2023	MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629	655 units	Class I	Ongoing	23 Aug 2023
Z-2379-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP	7293 units	Class I	Ongoing	23 Aug 2023
Z-2380-2023	MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637	775 units	Class I	Ongoing	23 Aug 2023
Z-2381-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP	2425 units	Class I	Ongoing	23 Aug 2023
Z-2382-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions REF: 8888345512HP	600 units	Class I	Ongoing	23 Aug 2023
Z-2383-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions REF: 8888345520HP	295 units	Class I	Ongoing	23 Aug 2023
Z-2384-2023	MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF: 8888345603	45880 units	Class I	Ongoing	23 Aug 2023
Z-2385-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP	2685 units	Class I	Ongoing	23 Aug 2023
Z-2386-2023	MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611	69987 units	Class I	Ongoing	23 Aug 2023
Z-2387-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit REF: 8888345611HP	32125 units	Class I	Ongoing	23 Aug 2023
Z-2388-2023	MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629	6949 units	Class I	Ongoing	23 Aug 2023
Z-2389-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit REF: 8888345629HP	15209 units	Class I	Ongoing	23 Aug 2023
Z-2390-2023	MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637	647 units	Class I	Ongoing	23 Aug 2023
Z-2391-2023	MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF: 8888345637HP	3965 units	Class I	Ongoing	23 Aug 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2023: 917
Share of these events in Class I: 10%
Product records in this event: 25Median of the firm: 2
Events of the firm on the register: 31

Other events of the firm

Other FDA enforcement events of Covidien LP
Initiated	Product (first record)	Type	Class	Records
24 Jun 2026	V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 GS-25 VLOCM0436 VLOCM0436 VLOCM	Device	Class II	5
15 Apr 2026	Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;	Device	Class II	1
25 Sep 2025	Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;	Device	Class II	2
19 Sep 2024	Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-	Device	Class II	1
15 Apr 2024	Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surge	Device	Class II	1
15 Mar 2024	Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silve	Device	Class II	2
28 Feb 2024	Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB	Device	Class II	7
14 Feb 2024	Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT	Device	Class II	2
25 Jan 2024	Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of	Device	Class II	1
21 Dec 2023	Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919	Device	Class II	2

Covidien LP: all 31 events

Official channels

FDA enforcement report Z-2367-2023The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 92660. https://recallregister.com/fda/i/92660/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide - Worldwide Distribution Foreign: Argentina Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Canada Cayman Islands China Costa Rica Czech Republic Denmark Dominican Republic…
What quantity of product is in FDA event 92660?: The event has 25 product records. The first record gives this quantity: 2370 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 10% of the 917 device events that started in 2023 are in Class I.