Boston Scientific Corporation Recall 93281
Description: EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
Boston Scientific Corporation Recall 93281 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0396-2024 |
| Event ID | 93281 |
| Event Description | EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0. |
| Product Type | Devices |
| Distribution | 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. |
| Quantity | US: 586 devices & OUS: 81 devices |
| Recall Reason | Poor image quality due to fluid ingress in the lens. |
| Device Classification | 20231129 |
| Device Code Info | UDI-DI (GTIN): 08714729983514, Outer box UPN# M00542420, Lot / Batch # 31137538, 31537335, 31228699, 31590604, 31257049, 31635405, 31257050, 31683854, 31258726, 31802917, 31329914, 31810037, 31398618, 31991955, 31438355, 32006891, 31473069, 32146684. UDI-DI (GTIN): 08714729995746, Outer box UPN# M0054242CE0, Lot / Batch # 31199348, 31712358, 31574944. |
| Center Classification Date | 20231121 |
| Recall Initiation Date | 20230927 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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