Five S 5 3x65, REF: 0915612-06, sterile for single use, Sterile EO, Rx Only

FDA device recall Z-2589-2023 · posted 2023-09-15 · Open, Classified

Recall details

Recalling firm

Karl Storz Endoscopy

Reason for recall

Flexible intubation endoscopes sterility assurance can not be confirmed.

Action taken

On August, 4, 2023, Karl Storz Endoscopy issued an Urgent Medical Device Recall Notification via: UPS. Karl Storz asked consignees to take the following actions: 1. Immediately quarantine and discontinue use of Material numbers listed above. 2. Pass on this Urgent Medical Device Recall notice to all users of the products listed above and all other persons who need to be aware within your organization. 3. If you have distributed the products listed, please promptly forward this letter to those recipients, and indicate contact details of the recipient on the Customer Reply From. 4. Return the filled Customer Reply Form by Fax or E-Mail to the indicated contact. 5. Get in touch with your KARL STORZ representative to return affected products. 6. Please report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback. 7. (Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.)

Root cause

Process change control

Status

Open, Classified

Product code

EOQ

Quantity affected

218 units

Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MEX, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, O

Date initiated

2023-07-07

Date posted

2023-09-15

Location

El Segundo, CA

Related 510(k) clearances