DYND70000 Medicine Cup 30 mL

Starting date:

November 18, 2016

Posting date:

December 13, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-61424

• Reason
• Affected products

Reason

The medicine cups have gradation markings on the side in millilitres. The increments are 2.5, 5, 7.5, 10, 12.5, 15, 20, 25, 30 mL. Some cups repeat the 5 mL mark at the 10 mL location so that the increments appear as: 2.5, 5, 7.5, 5, 12.5, 15, 20, 25, 30 mL. Therefore a certain number of cups in each case of product will have incorrect markings. The cups are injection molded on a machine that has 64 cavities (a cavity is a mold for a cup). Therefore 64 cups can be produced at once with each injection of material. Each cavity is numbered and the number is embossed on the bottom of the cup. Cavity #44 is the defective mold with the incorrect increments. Therefore every cup numbered #44 on the bottom will have the defect. The cups are packaged in sleeves of 100 stacked cups and packaged 500 stacks in a case (5,000 cups). There will be 2, 4, or 6 sleeves containing cups from cavity #44 in a case, which comes out to 50-150 cups per case. This is based on how the robot stacks, combines, and bags the product. Therefore there is the potential for 150 defective cups in a case.

Affected products