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Instrumed International, Inc. recalls A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant so
Recalled December 17, 2014 · FDA recall Z-0538-2015 · Instrumed International
Hazard
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices. · FDA Class II
Units
421 clamps
Sold at
Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
Description
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Product
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, Surgipro, Teleflex Medical, Boss Instruments, Symmetry Surgical, Phoenix Instruments, GICAL, and CareFusion brand names.
Manufacturer(s)
Instrumed International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →