Device Recall CIVCO SurgiTip Transducer cover

  • Model / Serial
    Lot M538160
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: the states of OH, MD, NE, VA, IA, MI, WA, and WI.
  • Product Description
    CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Civco Medical Instruments Inc, 102 1st St S, Kalona IA 52247-9589
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of CA, IL, MA, MI, MO, and WI.
  • Product Description
    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