Z-1991-2023 Class II Ongoing
FDA device recall Z-1991-2023 was initiated by Karl Storz Endoscopy on April 6, 2023 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 4,933.
Recall Details
- Product Type
- Devices
- Report Date
- June 28, 2023
- Initiation Date
- April 6, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,933
Product 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
Reason for Recall
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.
Distribution Pattern
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.
Code Information
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.