Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-1075-05 · Posted 2005-08-03

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeGES
Date Initiated2005-04-19
Date Terminated2006-10-03
Product Quantity48000 units

Reason for Recall

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

Firm Action

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

Root Cause

Other

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑