Device recall: Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and…
Class II FDA enforcement event 75301. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Product sterility is compromised due to breach of the sterile barrier
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
Medtronic started this device recall on 4 Oct 2016. The firm address in the FDA record is in North Haven, CT. FDA put the recall in Class II. FDA event 75301 has 2 product records. The first FDA enforcement report date is 28 Dec 2016. The record gives the status Terminated, with the termination date 8 Aug 2018.
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.
Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait…
Recalling firm
Medtronic, North Haven, CT.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0889-2017 | Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens | 1,293,169 systems | Class II | Terminated | 28 Dec 2016 |
| Z-0890-2017 | Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens | 230 systems | Class II | Terminated | 28 Dec 2016 |
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 2016
- 1,232
- Share of these events in Class II
- 91%
- Product records in this event
- 2Median of the firm: 4
- Events of the firm on the register
- 7
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 May 2017 | Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSOR | Device | Class II | 8 |
| 8 Feb 2017 | BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01 | Device | Class II | 5 |
| 8 Jul 2016 | Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and | Device | Class II | 25 |
| 13 Apr 2016 | Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 0105 | Device | Class I | 1 |
| 1 Apr 2016 | Covidien Kangaroo Connect Enteral Feeding Pump Item Number: 384400 (US) Intended to provide enteral nutrition to a patie | Device | Class II | 2 |
| 2 Dec 2015 | Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal | Device | Class II | 4 |
Official channels
- FDA enforcement report Z-0889-2017The 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 75301. https://recallregister.com/fda/ii/75301/. 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:
Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait…
- What quantity of product is in FDA event 75301?
- The event has 2 product records. The first record gives this quantity:
1,293,169 systems
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 91% of the 1,232 device events that started in 2016 are in Class II.