Customer Service: 1-800-331-7993
November 10, 2014
The FDA has notified health professionals and their medical care organizations of the Class 1 recall of the Puritan Bennett 980 Ventilator Systems with software versions below 2.8, with distribution dates March 3, 2014 through August 22, 2014 and serial numbers listed here. The recalled products have a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected, which could lead to serious health problems or death.
RECOMMENDATION: Covidien sent an Urgent Field Corrective Action letter dated October 3, 2014 to its customers. A Covidien representative will update the software on the ventilators as soon as possible. To receive the software update, complete the acknowledgement and receipt form attached to the correction letter. Fax it to the Covidien contact found on the form.
Customers may continue to use these ventilators until Covidien updates the software, as long as two gas sources are connected to the ventilator at all times. See the recall notice at the link below for other Covidien reminders and instructions from the Corrective Action letter.
Read the MedWatch safety alert including a link to the Recall Notice at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm422362.htm
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
October 31, 2014
Practice Tips this month is getting a little dressed up for Halloween (you will want to read until the end for an American Dental treat). We are going to tell you a few "tricks" to keep your vacuum facts straight.
In the history of dental practices, infection control has had two major characters when it comes to chairside disposal: central vacuum canisters and debris baskets.
The assistant’s instrumentation (particularly the high volume evacuator valve) is your first line of defense in infection control as it reduces contaminated aerosols which can spread blood borne pathogens which can contribute to cross-contamination.
The high volume evacuator (HVE) and Saliva Ejector (SE) are often collectively referred to as the “assistant’s instrumentation” and will both connect to a collection canister or “chairside trap” as many refer to it.
The collection canister serves two primary functions:
One: Splits the main vacuum line from the central vacuum so you can have multiple vacuum valves in the operatory. Most canisters have 4 ports on the bottom, 2 for the HVE, one for the SE, and one to connect to the main line from the central vacuum. The different vacuum valves will reduce the expulsion of contaminated aerosols into the operatory, evacuate fluids from the oral cavity to improve visibility and allow bonding of various materials, and can even be used in conjunction with nitrous oxide to scavenge exhaled gases . In fact, the 2nd HVE port is often dedicated to a valve to use with your scavenger circuit.
It is fairly common for the 2nd HVE port to be plugged with a port plug on new equipment. The port plug available from American Dental Accessories is different from most plugs in that it is tapered so it will fit inside the HVE port and outside the SE port. One plug can thus be used for either port. This plug is also made of a long lasting synthetic rubber rather than the thin plastic caps used by many equipment manufacturers.
Two: Filter solids picked up by the HVE valve(s). As you can see in the photo below, the HVE ports poke up through the collection canister, so solid debris picked up will be caught in the basket. The SE normally only picks up liquids, so the SE port does not penetrate the basket.
American Dental Accessories, Inc. carries 3 styles of collection canisters, referred to as types “A”, “B” and “C”:
The Type “B” canister has a ½” outside diameter port to connect to the central vacuum line (the same size as the HVE ports). This is also the smallest canister with a basket (filter screen) that is only 1-7/8” in diameter. Because of the small size, the HVE ports are off center. This off-center design is unique to the type “B” canister. If using color-coded baskets, the baskets for a Type “B” canister are green.
The type “A” and type “C” canisters both have a 5/8” port to connect to the line from the central vacuum (“drain port”) so they can offer superior suction. The overall size of the canister is bigger and they accept a basket that is 2-1/8” in diameter. The larger size allows placing the HVE ports along the diameter of the canister (and basket). There are other older designs that have this feature as well, however, so having ports along the diameter is not a clear indicator of which canister (or basket) one might have. If using color-coded baskets, the basket for the type “A” and “C” canisters is blue.
The “A” and “C” canisters are distinguished from each other by the location of the drain port. The “A” canister has the 5/8” drain port on the bottom of the canister, the “C” canister has the port coming out of the side of the canister. The side drain allows the “C” canister to be used at the end of telescoping arms (#08-98 for example) or in other configurations that may not allow for a drain on the bottom. With a telescoping arm mount, the side port allows the drain line to feed through the arm aiding in asepsis and giving the unit clean aesthetics.
When you look at vacuum canisters and debris baskets in such a way, they aren't quite the scary and characters for Halloween that we are used to. Just remember to watch out for the location of the HVE ports of the canister and the correlating baskets.
We hope you liked our version of Halloween Practice Tips this month. We have a treat for you! By mentioning this blog post, you can buy one vacuum canister and receive a pkg. of 10 correlating baskets (#18-90 or #18-91) for free (call 800.331.7993 to order)! Check back next month for another installment.
October 20, 2014
Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free (NDC 0409-4279-02; Lot 40-316-DK, Expiry 1APRIL2016) to the user level due to a confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, embedded in and attached to a pinched area of the stopper.
For detailed information pertaining to this Recall consult Hospira or the FDA.