Device recall: 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid…
Class II FDA enforcement event 83324. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
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 13 Mar 2019. The firm address in the FDA record is in Harleysville, PA. FDA put the recall in Class II. FDA event 83324 has 3 product records. The first FDA enforcement report date is 14 Aug 2019. The record gives the status Terminated, with the termination date 5 Mar 2024.
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.
US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
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
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2215-2019 | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter | 6830 | Class II | Terminated | 14 Aug 2019 |
| Z-2216-2019 | 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter | 6830 | Class II | Terminated | 14 Aug 2019 |
| Z-2217-2019 | 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter | 6830 | Class II | Terminated | 14 Aug 2019 |
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 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 17
Other events of the firm
Official channels
- FDA enforcement report Z-2215-2019The 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 83324. https://recallregister.com/fda/ii/83324/. 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:
US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
- What quantity of product is in FDA event 83324?
- The event has 3 product records. The first record gives this quantity:
6830
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.