| Class 2 Device Recall Boss Instruments, Millennium Surgical, Symmetry Surgical, Medline Industries, CareFusion, etc. | |
Date Initiated by Firm | September 08, 2014 |
Date Posted | December 16, 2014 |
Recall Status1 |
Terminated 3 on November 29, 2017 |
Recall Number | Z-0538-2015 |
Recall Event ID |
69471 |
Product Classification |
Clamp, circumcision - Product Code HFX
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Instrumed International, Inc. 626 Cooper Ct Schaumburg IL 60173-4537
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For Additional Information Contact | Ms. Jennifer S. Staunton 847-908-6119 |
Manufacturer Reason for Recall | 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 Determined Cause 2 | No Marketing Application |
Action | Instrumed sent an URGENT: MEDICAL DEVICE MARKET WITHDRAWAL letters dated October 9, 2014 to all affected customers. The letter included instructions for customers to: 1) examine their inventory to determine if there are any recalled devices; 2) complete and return the enclosed Confirmation Request Form; 3) return the recalled devices; and 4) share the recall information with facility staff. Customers with questions were instructed to contact Instrumed by telephone at 847-908-6119. |
Quantity in Commerce | 421 clamps |
Distribution | Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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