FDAFDA · Food and drugs·Recall number Z-0538-2015
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.
Published December 17, 2014 · Recall initiated: September 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instrumed International, Inc.
- Distributor
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Lot
- 1) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex Medical Product Name: CLAMP MOGEN; Teleflex Medical Item Number: P-16310; Lot Numbers: 010214, 030113, 050114, 060313, 100112. 2) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Boss Instruments; Boss Instruments Product Name: Mogan Circumcision Clamp, infant; Boss Instruments Item Number: 46-5190; Lot Numbers: 030113, 100112. 3) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Mogan Circumcision Clamp, infant; Millennium Surgical Item Number: 0-64227; Lot Numbers: 010214, 030112, 030113, 100112, 120413. 4) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Mogan Circumcision Clamp, infant; Phoenix Instruments Item Number: 185-6550; Lot Number: 080111. 5) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Mogan Circumcision Clamp, infant; Symmetry Surgical Item Number: 85-6550; Lot Numbers: 010214, 020411, 030112, 030113, 050114, 060313, 100112, 120111, 120413. 6) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: GICAL; GICAL Product Name: Mogan Circumcision Clamp, infant; GICAL Item Number: H156-7312; Lot Numbers: 010214, 030113. 7) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: CareFusion; CareFusion Product Name: Mogan Circumcision Clamp, infant; CareFusion Item Number: VM57-6201; Lot Numbers: 010214, 030113, 050114, 080111, 100112. 8) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed Product Number: 330-86212; Trade Name: Teleflex Medical; Teleflex MedicalProduct Name: Mogan Circumcision Clamp, infant; Teleflex MedicalItem Number: P-16310; Lot Number: 120111.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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