Karl Storz Endoscopy: Injection Needle, curved 23 cm, REF: 8598A; Injection Needle, straight, 23 cm, REF: 8598B; Injection Needle, distal 45-degrees, 23 cm, REF: 8598D

Hazard

The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

Details from the source

Reason for recall: The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection. Distribution: US: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI, VA, IN, IA, AR, TX, WV, MD, MN, GA, MA, NM, VT, AK, OR, ID, LA, KS, DC, KY, HI OUS: Mexica, Canada, Germany Quantity: 4,878 Lot/code info: REF/UDI-DI: 8598A/04048551213278, 8598B/04048551001462, 8598D/04048551213285 All lot numbers.

UPC codes

04048551213278, 04048551001462, 04048551213285

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.