Recalls / —

—#144193

Product

Vistec X-Ray Detectable Sponges, 26 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7321

FDA product code

LRS — I.V. Start Kit

Device class

Class 2

Medical specialty

General Hospital

Affected lot / code info

All lots beginning with 100000009962 through lot 15J163262X

Why it was recalled

Compromised sterility due to breach of barrier

Root cause (FDA determination)

Packaging process control

Action the firm took

Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878

Recalling firm

Firm

Covidien LLC

Address

60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern

Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.

Timeline

Recall initiated

2016-03-03

Posted by FDA

2016-05-31

Terminated

2017-06-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #144193. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.