Z-1036-2019 Class II Ongoing
FDA device recall Z-1036-2019 was initiated by ConvaTec, Inc on January 9, 2019 and is designated Class II. Reason for recall: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier. The recall status is ongoing. Affected quantity: 1,231,155 units total.
Recall Details
- Product Type
- Devices
- Report Date
- March 27, 2019
- Initiation Date
- January 9, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,231,155 units total
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of IL, MI, PA, WI. and the countries of Algeria, Australia, Austria, Belgium, Canada, Croatia, Czechia, Czech Republic, Denmark, Egypt, Estonia, Finland, Faroe Islands, France, Germany, Greece, Hong Kong, Hungary, Iceland, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Myanmar, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Spain, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, United States, Vietnam.