—#29260

Product

CordisEndomyocardial Biopsy Forceps 7F 104 cm Standard, Product Number 504300L

FDA product code: GEN — Forceps, General & Plastic Surgery
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number 70403255

Why it was recalled

Some devices may have an incorrect inner label which shows Product # 504302L with a length of 50cm, while the outer label is correctly labeled as Product # 504300L with the length of 104mm.

Root cause (FDA determination)

Other

Action the firm took

The firm initially sent Cordis representatives to visit all 21 domestic accounts the week of August 25, 2003. Follow-up Recall notificaiton Letters were sent to each account discussing the problem and informing them that a Cordis Representative has been at their location and inspected their product for misbranded devices. In 18 cases the letter stated that NO mislabeled product was found but in three other cases they were told that mislabeled product was found and recovered. These follow-up letters to the visits were sent out on August 29, 2003. A similar inspection was performed by Cordis Representatives for International Accounts and the Recall Notification was sent to the International Accounts on 8/29/2003.

Recalling firm

Firm: Cordis Corporation
Address: 14201 N.W. 60th Ave, Miami Lakes, Florida 33014

Distribution

Distribution pattern: The devices were distributed to 21 domestic hospital accounts in MI, OK, FL, TN, NY, IN, VA, NC, WI, GA, IA, NE, CA. Also product was distributed to International Distributors in the Netherlands, Canada and Mexico.

Timeline

Recall initiated: 2003-08-29
Posted by FDA: 2004-07-20
Terminated: 2004-05-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #29260. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.