FDA recalls two sutures; sterility in question
August 1, 1999 less than 1 minute read
FDA recalls two sutures; sterility in question
There are two recently published FDA Class II recalls related to compromised suture sterility, according to the Health Devices Alerts Database of Plymouth Meeting, PA-based ECRI, an international nonprofit health services research agency. FDA Enforcement Report 1999 Jan. 13, recall # Z-349/354-9, relates to Zimmer Statpak suture kits, and FDA Enforcement Report 1999 Jan. 27, recall # Z-426/462-9, relates to a variety of United States Surgical sutures. The Health Devices Alerts Data base is available on CD-ROM (updated quarterly), through weekly print notices, or through ECRI’s Web site at www.healthcare.ecri.org. When there, search the site for "Health Devices Alerts Data base." Contact ECRI at (610) 825-6000, ext. 5223.
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