MINI-DAP, MICRO-DAP DIPHOTERINE (2019-04-19)

Starting date:

April 19, 2019

Posting date:

May 10, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69868

Last updated: 2019-05-10

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  Reason
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  Affected products

Affected Products

1. MINI-DAP DIPHOTERINE
2. MICRO-DAP DIPHOTERINE

Reason

Damage inflected on the product (such as severe shocks), after delivery during the storage, lead to mechanical constraints between the valve and the pouch containing the solution which lead to a tear of the pouch that created a leak into the can. Consequently, the DIPHOTERINE solution was spread inside the canister and the MINI-DAP of DIPHOTERINE solution was not operating anymore.

Affected products