—#38901

Product

BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab incisions''. A non sterile, disposable, stainless steel blade. Reorder Number 371631.

FDA product code: GES — Blade, Scalpel
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number 4322604.

Why it was recalled

A small percentage of scalpels exhibited a 'double blade' condition.

Root cause (FDA determination)

Other

Action the firm took

Letters were sent to all customers and all customers have also been contacted by phone. Letters were sent on 4/49/2005.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: The scalpels were distributed to kit manufacturers. These include: Cardinal Health, 1300 Waukegan Road, McGaw Park, Il 60085; Bard Health Care, 201 West Anaya Road, Hidalgo, TX 78577; Edwards Lifesciences, 6864 South 300 West, Salt Lake City, UT 84047; Avid Medical, 900 Westmount Dr., James City, VA 23168; DeRoyal Industries, PO Box 1667, Knoxville, TN 37849; Boston Scientific, 780 Brookside Dr., Owen, IN 47460; Medikmark, 3600 Burwood Dr., Waukegan Lake, IL 60085; CustoMed/Puerto Rico Hospital Supply, Carolina, PR 00987.

Timeline

Recall initiated: 2005-04-19
Posted by FDA: 2005-08-03
Terminated: 2006-10-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38901. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.