FDA URGENT INFORMATION
Recall of Clinipad Sterile Products Used in Prepackaged Procedure Kits
and Trays
March 29, 2000
(You are encouraged to copy and distribute this information)
To: Hospital Administrators
Risk Managers
Director, Central Supply
Ambulatory Surgery Centers
Dialysis Centers
I am writing to let you know that certain prepackaged procedure kits
and trays may include sterile antiseptic skin preparations that have been
recalled by Clinipad Corporation because they may not be sterile. More
than 140 manufacturers prepare a variety of procedure kits and trays that
include one or more of these recalled products.
Recommendations
- Do not use any recalled Clinipad Corporation products.
- You should be receiving Urgent Device Recall letters from the manufacturers
of affected procedure kits and trays used in your facility. Each manufacturer
may handle the recall of their kits and trays differently. Follow
the directions provided by each manufacturer for their kits and trays.
Even if the kit or tray manufacturer does not contact you, you still
should not use any of the recalled Clinipad products. Keep in mind that
unless stated otherwise by the manufacturer, only the Clinipad product
from each kit or tray is being recalled.
- If you assemble custom kits for use in your facility, be sure to
remove all recalled products from these kits.
Clinipad Corporation Products Included in the Recall
The nationwide recall of the Clinipad sterile-products line includes
Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol
and Alcohol Antiseptic Products as well as Sterile Cliniguard® Protective
Dressing labeled as "sterile." The recall includes all such products manufactured
since January 1, 1997. The products (swabsticks, prep pads, towelettes,
ointment tubes and pouches, and protective dressings) are distributed
under the names: Cliniswab, Clinipad, Clinidine, Cliniguard, EZ Prep,
Cooper Instrument Corp., Moore Medical Corp., and Rauscher. They are sold
separately or packaged in various manufacturer prepared procedure kits
and trays and are widely distributed to blood banks, hospitals, clinics,
and retail pharmacies. They are used to prepare the skin prior to invasive
procedures.
All lots of the sterile products involved in the recall have a lot number
beginning with 7, 8, 9, or 0, and are labeled as "sterile" or "sterile
unless opened or damaged" on the unit of use packaging.
Reason for the Recall
The reason for the Clinipad Corporation recall is that the company has
confirmed bacterial contamination in some lots of its sterile products,
including one lot with Pseudomonas aeruginosa, Stenotrophomonas
maltophilia, and coagulase negative Staphylococcus, and therefore
cannot assure the sterility of its products labeled and sold as sterile.
These organisms can cause skin, wound, or other infections that may be
serious or life threatening in some cases.
Additional Information
For facilities whose current procedure includes the use of the recalled
prepackaged products, FDA's Center for Biologics Evaluation and Research
has posted information on its web site regarding methods and products
that may be used for skin preparation prior to the collection of blood
and blood components. The web address is http://www.fda.gov/cber/infosheets.htm.
Additional information regarding these recalls can also be found on the
FDA's MedWatch web site at http://www.fda.gov/medwatch/safety/2000/safety00.htm.
The Clinipad Corporation can be contacted at 860-571-0100.
Questions regarding this letter can be e-mailed to phann@cdrh.fda.gov;
faxed to Merrith Wilson at 301-594-2968; or submitted in writing to Merrith
Wilson at FDA, CDRH, Office of Surveillance and Biometrics, HFZ-510, 1350
Piccard Drive, Rockville, MD 20850.
Additional copies of this notification, as well as all of FDA's medical
device postmarket safety notifications, can be found on the FDA web site
at http://www.fda.gov/cdrh/safety.html.
Postmarket safety notifications can also be obtained through e-mail on
the day they are released by subscribing to our list server. Subscribe
at: http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10
Reporting Adverse Events
FDA solicits your help in collecting data on adverse events related to
medical devices. Healthcare professionals employed by healthcare facilities
that are subject to FDA's user facility reporting requirements should
follow the reporting procedures established by their facility. Practitioners
can also report incidents directly to MedWatch, the FDA's voluntary reporting
program. The reports can be submitted by phone at 800-FDA-1088; by fax
at 800-FDA-0178; via the MedWatch web site at http://www.fda.gov/medwatch;
or by mail to MedWatch, FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20857.
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Sincerely yours,
David W. Feigal, Jr., M.D., M.P.H.
Director,
Center for Devices and Radiological Health |
Updated March 30, 2000
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