Karl Storz Endoscopy Recall 92244
Description: Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39501A2; Wire Tray f. Cleaning, 487 x 125 x 54 mm, REF: 39501B2; Wire Tray for ENDOCAMELEON, REF: 39501BEC; Tray, with lid, 670x80x52mm, REF: 39501C; Wire Tray for ENDOCAMELEON, long version, REF: 39501CEC; Wire Tray Retromolar Intub. Endoscope, REF: 39501F; Wire basket for c-mac videolaryngoscope, REF: 39501LC2; Tray, URS, 644 x 150 x 80 mm, REF: 39501X; Wire Tray, URS, REF: 39501XK; Wire tray PECD, REF: 39501XP; Tray, paranasal sinus shaver system, REF: 39550A
Karl Storz Endoscopy Recall 92244 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1991-2023 |
| Event ID | 92244 |
| Event Description | Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39501A2; Wire Tray f. Cleaning, 487 x 125 x 54 mm, REF: 39501B2; Wire Tray for ENDOCAMELEON, REF: 39501BEC; Tray, with lid, 670x80x52mm, REF: 39501C; Wire Tray for ENDOCAMELEON, long version, REF: 39501CEC; Wire Tray Retromolar Intub. Endoscope, REF: 39501F; Wire basket for c-mac videolaryngoscope, REF: 39501LC2; Tray, URS, 644 x 150 x 80 mm, REF: 39501X; Wire Tray, URS, REF: 39501XK; Wire tray PECD, REF: 39501XP; Tray, paranasal sinus shaver system, REF: 39550A |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution including in the states of IN, MS, MN, AZ, FL, IL, CA, AK, NY, VA, TX, PA, LA, ND, AS, MD, NH, SC, AR, GA, NJ, NC, WA, WI, SD, TN, KY, AL, OK, MO, MA, MI, CT, UT, WY, CO, OH, DC, DE, NM, MT, ME, OR, PA, WV, IA, NE, HI, KS, ID, NV, RI, VT, GU and the country of CA. |
| Quantity | 4,933 |
| Recall Reason | Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tray models, that also includes information regarding the sterilization modality. |
| Device Classification | 20230628 |
| Device Code Info | REF/UDI-DI: 11580A/ 04048551051801; 11580B/ 04048551051818; 11580C/ 04048551051825; 11580D/ 04048551051832; 39501A1/ 04048551157619; 39501A2/ 04048551157626; 39501B2/ 04048551157657; 39501BEC/ 04048551241400; 39501C/ 04048551157671; 39501CEC/ 04048551254158; 39501F/ 04048551157695; 39501LC2/ 04048551273432; 39501X/ 04048551157756; 39501XK/ 04048551157763; 39501XP/ 04048551157770; 39550A/ 04048551157879. All lots. |
| Center Classification Date | 20230621 |
| Recall Initiation Date | 20230406 |
| Recalling Firm | Karl Storz Endoscopy |
| Initial Notification | Letter |
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