Device recall: Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
Class II FDA enforcement event 83839. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules
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
Candela Corporation started this device recall on 10 Sep 2019. The firm address in the FDA record is in Wayland, MA. FDA put the recall in Class II. FDA event 83839 has 4 product records. The first FDA enforcement report date is 30 Oct 2019. The record gives the status Terminated, with the termination date 20 Oct 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.
States: NC GA CA MA OH FL IL CO SD NY KS WA MI PA AZ WI TX LA IA MN VA TN SC OR IN WY MD VT ON BC QC NV OUS: Barbados Canada Germany Spain France HR Portugal Ireland Norway Greece NL South Africa…
Recalling firm
Candela Corporation, Wayland, MA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0206-2020 | Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser. | in total 7,560 canisters (3240 additional as of 2/5/20) | Class II | Terminated | 30 Oct 2019 |
| Z-0207-2020 | Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser. | 386 cases ( 15 pack canister/ case) (216 additional cases as of 12/09/19) | Class II | Terminated | 30 Oct 2019 |
| Z-0208-2020 | Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser. | in total 7,560 canisters (3240 additional as of 2/5/20) | Class II | Terminated | 30 Oct 2019 |
| Z-0209-2020 | Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser. | in total 7,560 canisters (3240 additional as of 2/5/20) | Class II | Terminated | 30 Oct 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
- 4Median of the firm: 4
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Nov 2013 | Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Event 66773 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0206-2020The 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 83839. https://recallregister.com/fda/ii/83839/. 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:
States: NC GA CA MA OH FL IL CO SD NY KS WA MI PA AZ WI TX LA IA MN VA TN SC OR IN WY MD VT ON BC QC NV OUS: Barbados Canada Germany Spain France HR Portugal Ireland Norway Greece NL South Africa…
- What quantity of product is in FDA event 83839?
- The event has 4 product records. The first record gives this quantity:
in total 7,560 canisters (3240 additional as of 2/5/20)
- 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.