Device recall: Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
Class II FDA enforcement event 80581. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
Class II, in the words of FDA
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
Medical Components, Inc dba MedComp started this device recall on 12 Jul 2018. The firm address in the FDA record is in Harleysville, PA. FDA put the recall in Class II. FDA event 80581 has 11 product records. The first FDA enforcement report date is 5 Sep 2018. The record gives the status Terminated, with the termination date 2 Jul 2020.
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 . openFDA export of .
Distribution
In the words of FDA.
Nationwide distribution; worldwide distribution.
Recalling firm
Medical Components, Inc dba MedComp, Harleysville, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2932-2018 | Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108 | N/A | Class II | Terminated | 5 Sep 2018 |
| Z-2933-2018 | Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15 | N/A | Class II | Terminated | 5 Sep 2018 |
| Z-2934-2018 | Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set; DL11/24 . Hemodialysis catheter insertion kits | N/A | Class II | Terminated | 5 Sep 2018 |
| Z-2935-2018 | Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ | N/A | Class II | Terminated | 5 Sep 2018 |
| Z-2936-2018 | Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits | N/A | Class II | Terminated | 5 Sep 2018 |
| Z-2937-2018 | Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 | N/A | Class II | Terminated | 5 Sep 2018 |
| Z-2938-2018 | Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M | N/A | Class II | Terminated | 5 Sep 2018 |
| Z-2939-2018 | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424 | N/A | Class II | Terminated | 5 Sep 2018 |
| Z-2940-2018 | SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M | N/A | Class II | Terminated | 5 Sep 2018 |
| Z-2941-2018 | DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67 | N/A | Class II | Terminated | 5 Sep 2018 |
| Z-2942-2018 | DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FLOW IJ DOUBLE LUMEN CATHETER W/SOFT TIP SET, W/MINI SCALPEL, SYRINGE, AND NEEDLE, XTP118IJS-ID;… | N/A | Class II | Terminated | 5 Sep 2018 |
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 II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 11Median of the firm: 1
- Events of the firm on the register
- 17
Other events of the firm
Official channels
- FDA enforcement report Z-2932-2018The 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.
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Cite this page
Recall Register. FDA enforcement event 80581. https://recallregister.com/fda/ii/80581/. Source: openFDA enforcement reports. Data through .
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:
Nationwide distribution; worldwide distribution.
- What quantity of product is in FDA event 80581?
- The event has 11 product records. The first record gives this quantity:
N/A
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.