FDA-Device2015-04-15Class II
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.
Civco Medical Instruments Inc
Hazard
Leaks were detected in the recalled lot which may compromise the sterility of the product.
Sold states
Distributed to the states of CA, IL, MA, MI, MO, and WI.
Affected count
120 pouches
Manufactured in
102 1st St S, N/A, Kalona, IA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1400-2015Don't want to check this manually?
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