PlainRecalls
FDA Devices Moderate Class II Ongoing

Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A

Reported: December 27, 2023 Initiated: October 24, 2023 #Z-0572-2024

Product Description

Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A

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.

Details

Recalling Firm
Karl Storz Endoscopy
Units Affected
990
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
Location
El Segundo, CA

Frequently Asked Questions

What product was recalled?
Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A. Recalled by Karl Storz Endoscopy. Units affected: 990.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 27, 2023. Severity: Moderate. Recall number: Z-0572-2024.