Atlas FDA

BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab incisions''. A non sterile, disposa

FDA device recall Z-1075-05 · posted 2005-08-03 · Terminated

Recall details

Recalling firm
Becton Dickinson & Company
Reason for recall
A small percentage of scalpels exhibited a 'double blade' condition.
Action taken
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
Status
Terminated
Product code
GES
Quantity affected
48000 units
Distribution
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 Lifescie
Date initiated
2005-04-19
Date posted
2005-08-03
Date terminated
2006-10-03
Location
Franklin Lakes, NJ

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.