Device 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.
Z-1400-2015
Product summary
- Event
- Event 70719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 120 pouches
- Official record key
device-enforcement:Z-1400-2015
Official wording
Reason: Leaks were detected in the recalled lot which may compromise the sterility of the product.
Code information: Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01
Distribution pattern: Distributed to the states of CA, IL, MA, MI, MO, and WI.
Derived failure modes
-
Unknown
Leaks were detected in the recalled lot which may compromise the sterility of the product.