—#206462

Product

Hemostasis Probe, Model: CD-B622LA

FDA product code: KNS — Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K123319
Affected lot / code info: Model Number: CD-B622LA; UDI/DI: 00821925039452; Lot Number: KR214212

Why it was recalled

The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.

Root cause (FDA determination)

Employee error

Action the firm took

On January 30, 2024, the firm notified its only customer of the issue via URGENT: MEDICAL DEVICE FIELD REMOVAL ACTION letters. Actions to be taken by the end user: 1. Inspect your inventory and identify any products of the model and lot subject to this action. Please check all areas of the hospital to determine if any of these devices remain in inventory. Quarantine and cease use of the affected model/lot. 2. Please contact your Regional Customer Service, with the quantity, model and lot number of the affected device(s). Olympus will issue a Return Material Authorization to return any affected product at no charge. Olympus will issue a credit to your facility upon return of the affected product. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number "XXXX and provide your contact information as indicated in the portal. 4. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests you to report any complaints, including mispackaging, to your Regional Complaint Intake Contact. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact your regional contact person.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: International distribution only.

Timeline

Recall initiated: 2024-01-05
Posted by FDA: 2024-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206462. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.