Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K

FDA device recall Z-1995-2012 · posted 2012-07-12 · Terminated

Recall details

Recalling firm

PSC Industries Inc

Reason for recall

Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps are misbranded in that the label states that the tip size is: (0.5mm) when the tip size actually measures (1.0mm).

Action taken

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

Status

Terminated

Product code

GEI

Quantity affected

5 units

Distribution

Worldwide distribution: USA (nationwide) including states of: CA, CT, FL, GA, MD, MI, NC, OR, SC, and TX and countries of: Canada and Philippines.

Date initiated

2012-06-01

Date posted

2012-07-12

Date terminated

2015-09-15

Location

Louisville, KY

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