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FDA (Device enforcement)Recalled 2018-11-02class ii

Baxter Healthcare Corporation: GEM Coupler Forceps, GEM4183C, packaged individually.

Is my product affected?

GEM Coupler Forceps, GEM4183C, packaged individually.

  • UPC 00844735002850

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling 123 units of GEM Coupler Forceps (model GEM4183C) packaged individually due to the potential presence of rust on the devices. The affected product has Product Code 5193-06001-010, Lot Number SP18E129-1307852, Sub-lot Number 90828, and UDI 00844735002850. The devices were distributed nationwide to California, Florida, Georgia, Kansas, Louisiana, Massachusetts, Mississippi, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas, Utah, Virginia, Washington, and West Virginia, as well as internationally to the United Kingdom, Germany, South Africa, Japan, and Australia.

The source document does not specify a remedy or what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential presence of rust on Coupler Forceps (GEM4183C).

Details from the source

Reason for recall: Potential presence of rust on Coupler Forceps (GEM4183C). Distribution: Nationwide distribution to CA, FL, GA, KS, LA, MA, MS, NE, NJ, NV, NY, OH, PA, TX, UT, VA, WA, WV. International distribution to United Kingdom, Germany, South Africa, Japan, and Australia Quantity: 123 devices Lot/code info: Product Code 5193-06001-010, Lot Number: SP18E129-1307852, Sub-lot Number: 90828, UDI: 00844735002850

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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