Z-1099-2018 Class II Terminated
FDA device recall Z-1099-2018 was initiated by Boston Scientific Corporation on December 12, 2017 and is designated Class II. Reason for recall: Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. The recall status is terminated (terminated October 24, 2019). Affected quantity: 422.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- December 12, 2017
- Termination Date
- October 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 422
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: US (nationwide) in the following: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KA, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including the District of Columbia and Puerto Rico; and countries of: Argentina, Bolivia, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Mexico, Panama, Peru, Venezuela, Australia, Bangladesh, Botswana, China, Kuwait, Lebanon, Macau, Malaysia, Philippines, Saudi Arabia, Singapore, South Africa, South Korea, Turkey, United Arab Emirates, and Zimbabwe.