Z-1593-2023 Class II Ongoing
FDA device recall Z-1593-2023 was initiated by Boston Scientific Corporation on April 5, 2023 and is designated Class II. Reason for recall: The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool. The recall status is ongoing. Affected quantity: 10833 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- April 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10833 units
Product Description
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Reason for Recall
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
Distribution Pattern
Worldwide
Code Information
GTIN 08714729965770 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30319836,30359588,30368418,30392647,30409465,30421836, 30442123,30522919,30564343,30577971,30593836,30600837, 30600839,30601021,30616553,30620297,30625219,30638465, 30638467,30638469,30638471,30665570,30666996,30681966, 30681968,30681970,30712588,30725194,30780665,30801487, 30801489,30801491,30811488,30845828,30845830,30845832, 30885087,30890263,30890265,30914070,30922072,30929565, 30935495,30935497,30935499,30981820