Civco Medical Instruments Inc recalls CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm)…

Recall date

February 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1400-2015

FDA classification

Class II

Brand / firm

Civco Medical Instruments Inc

Sold / distributed

Distributed to the states of CA, IL, MA, MI, MO, and WI.

Why it was recalled

Leaks were detected in the recalled lot which may compromise the sterility of the product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocavity and intra-operative diagnostic ultrasound.