Recall StatusTerminated
Date Initiated2012-06-01
Date Terminated2015-09-15
Product Quantity7 units
Reason for Recall
Firm officials reported to CIN-DO that their Bipolar Bayonet Forceps 7.75" are misbranded in that the manufacturer symbol was replaced by the expiry symbol on the packaging.
Firm Action
The firm, Olsen Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated June 5, 2012 to their customers via Certified mail along with representative labeling to illustrate the specific labeling issue associated with the various types and/or sizes of Bayonet Forceps surgical instruments that the customers received. The letter described the product, problem and actions to be taken. The letter instructed the customers to immediately examine their inventory for the presence of the suspect product and quarantine the product, if found; to discontinue use immediately and promptly call (800) 251-3000 for a 'Return Material Authorization (RMA) number; to complete and return the enclosed 'Recall Response Form' and fax the completed form to the fax number on the form or to send the completed form back to the recalling firm via parcel post, and for customers who may have further distributed the recalled product are asked to contact their (sub-account) customers and notify them of the recall.
If you have any questions call (615) 964-5515 M-F 8:00 am - 5:00 pm CST.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.