Home / Recalls / Medical Devices
Civco Medical Instruments Inc recalls CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) N
Recalled April 15, 2015 · FDA recall Z-1400-2015 · Civco Medical Instruments
Hazard
Leaks were detected in the recalled lot which may compromise the sterility of the product. · FDA Class II
Units
120 pouches
Sold at
Distributed to the states of CA, IL, MA, MI, MO, and WI.
Description
Leaks were detected in the recalled lot which may compromise the sterility of the product.
Product
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.
Manufacturer(s)
Civco Medical Instruments Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →