Z-0397-2024 Class II Ongoing
FDA device recall Z-0397-2024 was initiated by Boston Scientific Corporation on September 27, 2023 and is designated Class II. Reason for recall: Poor image quality due to fluid ingress in the lens. The recall status is ongoing. Affected quantity: US: 5,709 devices & OUS: 180 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- September 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 5,709 devices & OUS: 180 devices
Product Description
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
Reason for Recall
Poor image quality due to fluid ingress in the lens.
Distribution Pattern
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA VT, WA, WI & WV. The countries of Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Great Britain, Italy, New Zealand, Spain, Sweden, Switzerland.
Code Information
UDI-DI (GTIN): 08714729993605, Outer box UPN# M00542421, Inner box UPN # M00542420, Lot / Batch # 31118200, 31537337, 31118202, 31538040, 31129470, 31544823, 31145980, 31544825, 31150536, 31590918, 31150537, 31591865, 31150538, 31607291, 31175587, 31619981, 31193809, 31627631, 31193810, 31636279, 31232040, 31643793, 31239963, 31676406, 31248263, 31683921, 31251918, 31692257, 31269307, 31697145, 31275008, 31706116, 31283026, 31710191, 31305347, 31718478, 31322088, 31726052, 31334176, 31729292,31338402, 31734350, 31347461, 31738755, 31348990, 31738756, 31357937, 31754162, 31360721, 31762358, 31366683, 31764634, 31373783, 31767053, 31409362, 31774421, 31416272, 31783669, 31424741, 31826665, 31429697, 31828975, 31430274, 31846317, 31440192, 31858409, 31447120, 31874720, 31454624, 31915555, 31458181, 31939608, 31462880, 32033589, 31472232, 32047032, 31474875, 32082692, 31537336. UDI-DI (GTIN): 08714729995753, Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0, Lot /Batch # 31118201, 31331654 31129503, 31817723, 31265893.