Device recall: Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset…
Class II FDA enforcement event 74602. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Potential for compromise of the package resulting in a 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 8 Jul 2016. The firm address in the FDA record is in North Haven, CT. FDA put the recall in Class II. FDA event 74602 has 25 product records. The first FDA enforcement report date is 24 Aug 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) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
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
25 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2554-2016 | Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes Item Code: E253028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 13420 | Class II | Terminated | 24 Aug 2016 |
| Z-2555-2016 | Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 19200 | Class II | Terminated | 24 Aug 2016 |
| Z-2556-2016 | Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 6" Item Code: E25306 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 19200 | Class II | Terminated | 24 Aug 2016 |
| Z-2557-2016 | Valleylab Laparoscopic Flexible Laparoscopic Argon Blade Electrodes 28CM Item Code: E258028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is… | 6769 | Class II | Terminated | 24 Aug 2016 |
| Z-2558-2016 | Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 3530 | Class II | Terminated | 24 Aug 2016 |
| Z-2559-2016 | Valleylab Laparoscopic Argon Sharp Needle Electrode 28CM Item Code: E258228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 210 | Class II | Terminated | 24 Aug 2016 |
| Z-2560-2016 | Valleylab Laparoscopic AP Argon Blunt Needle Electrode 28cm Item Code: E258328 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 2920 | Class II | Terminated | 24 Aug 2016 |
| Z-2561-2016 | Valleylab Laparoscopic Straight Spatula Electrode 36C Item Code: E277036 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 13516 | Class II | Terminated | 24 Aug 2016 |
| Z-2562-2016 | Valleylab Laparoscopic Curved Spatula Electrode 36CM Item Code: E277136 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 161940 | Class II | Terminated | 24 Aug 2016 |
| Z-2563-2016 | Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 6381 | Class II | Terminated | 24 Aug 2016 |
| Z-2564-2016 | Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277236 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 85630 | Class II | Terminated | 24 Aug 2016 |
| Z-2565-2016 | Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 349629 | Class II | Terminated | 24 Aug 2016 |
| Z-2566-2016 | Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 24870 | Class II | Terminated | 24 Aug 2016 |
| Z-2567-2016 | Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 119770 | Class II | Terminated | 24 Aug 2016 |
| Z-2568-2016 | Valleylab Laparoscopic Straight Spatula Electrode 28CM Item Code: E278028 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 6720 | Class II | Terminated | 24 Aug 2016 |
| Z-2569-2016 | Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | N/A | Class II | Terminated | 24 Aug 2016 |
| Z-2570-2016 | Valleylab Laparoscopic Curved Spatula Electrode Retractable 28CM Item Code: E2781R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | N/A | Class II | Terminated | 24 Aug 2016 |
| Z-2571-2016 | Valleylab Laparoscopic Wire J-Hook Electrode 28CM Item Code: E278228 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | N/A | Class II | Terminated | 24 Aug 2016 |
| Z-2572-2016 | Valleylab Laparoscopic Wire J-Hook Electrode Retractable 28CM Item Code: E2782R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 1440 | Class II | Terminated | 24 Aug 2016 |
| Z-2573-2016 | Valleylab Laparoscopic Wire L-Hook Electrode 28CM Item Code: E278328 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 42900 | Class II | Terminated | 24 Aug 2016 |
| Z-2574-2016 | Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 63320 | Class II | Terminated | 24 Aug 2016 |
| Z-2575-2016 | Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 50055 | Class II | Terminated | 24 Aug 2016 |
| Z-2576-2016 | Valleylab Laparoscopic Flat L-Hook Electrode 28cm Item Code: E278428 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 332 | Class II | Terminated | 24 Aug 2016 |
| Z-2577-2016 | Valleylab Laparoscopic Flat L-Hook Electrode Retractable Item Code: E2784R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | 3470 | Class II | Terminated | 24 Aug 2016 |
| Z-2578-2016 | Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single handset is desirable | N/A | Class II | Terminated | 24 Aug 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
- 25Median 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 |
| 4 Oct 2016 | Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparosc | Device | Class II | 2 |
| 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-2554-2016The 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 74602. https://recallregister.com/fda/ii/74602/. 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) and Internationally to Australia, Canada, Japan, Korea, Hong Kong, Thailand,
- What quantity of product is in FDA event 74602?
- The event has 25 product records. The first record gives this quantity:
13420
- 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.