Reported Dec 17, 2014 · Terminated
A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant…
Instrumed International, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumed International, Inc. · 626 Cooper Ct · Schaumburg, IL · 60173-4537
Is this the product you have?
- 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.
- Lot codes and dates
15 of 15 products
Products covered by this recall Model / number Product as published P-16310— 330-86212Lot Numbers: 010214, 030113, 050114, 060313, 100112. 2) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed ; Trade Name: Boss Instruments; Boss Instruments Product Name: Mogan Circumcision Clamp, infant; Boss Instruments 46-5190— 330-86212Lot Numbers: 030113, 100112. 3) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed ; Trade Name: Millennium Surgical; Millennium Surgical Product Name: Mogan Circumcision Clamp, infant; Millennium Surgical 0-64227— 330-86212Lot Numbers: 010214, 030112, 030113, 100112, 120413. 4) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed ; Trade Name: Phoenix Instruments; Phoenix Instruments Product Name: Mogan Circumcision Clamp, infant; Phoenix Instruments 185-6550— 330-86212Lot Number: 080111. 5) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed ; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Mogan Circumcision Clamp, infant; Symmetry Surgical 85-6550— 330-86212Lot Numbers: 010214, 020411, 030112, 030113, 050114, 060313, 100112, 120111, 120413. 6) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed ; Trade Name: GICAL; GICAL Product Name: Mogan Circumcision Clamp, infant; GICAL H156-7312— 330-86212Lot Numbers: 010214, 030113. 7) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed ; Trade Name: CareFusion; CareFusion Product Name: Mogan Circumcision Clamp, infant; CareFusion VM57-6201— 330-86212Lot Numbers: 010214, 030113, 050114, 080111, 100112. 8) Instrumed Product Name: Mogen Circumcision Clamp; Instrumed ; Trade Name: Teleflex Medical; Teleflex MedicalProduct Name: Mogan Circumcision Clamp, infant; Teleflex MedicalItem Number: P-16310 — Lot Number: 120111. - Amount recalled
- 421 clamps
This recall covers 28 products
The agency filed one notice per product. You are reading one of them; the other 27 are below.
15 more are in the archive.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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