Reported Dec 17, 2014 · Terminated
A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion,…
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 uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.
- Lot codes and dates
36 of 36 products
Products covered by this recall Model / number Product as published — Emmet Tenaculum Hook, #1 22.9 mm 310-21098Instrumed — Trade Name: CareFusion — CareFusion Product Name: Emmet Tenaculum Hook, #1 22.9 mm VM29-7112CareFusion — Lot Numbers: 07211, 100213. 2) Instrumed Product Name: Emmet Tenaculum Hook, #1 22.9 mm 310-21113Instrumed — Trade Name: TeleFlex Medical — Teleflex Medical Product Name: Emmet Tenaculum Hook, #1 22.9 mm VM29-7112Teleflex Medical — Lot Number: 100213. 3) Instrumed Product Name: Emmet Tenaculum Hook, #2, blunt 310-21113Instrumed — Trade Name: CareFusion — CareFusion Product Name: Emmet Tenaculum Hook, #2, blunt VM29-71131XCareFusion — Lot Number: 110110. 4) Instrumed Product Name : Emmet Tenaculum Hook, #5 310-21138Instrumed — Trade Name: Symmetry Surgical — Symmetry Surgical Product Name: Emmet Tenaculum Hook, #5 20-4205Symmetry Surgical - Amount recalled
- 26 tenaculum hooks
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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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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