Z-1400-2015 Class II Terminated
FDA device recall Z-1400-2015 was initiated by Civco Medical Instruments Inc on February 26, 2015 and is designated Class II. Reason for recall: Leaks were detected in the recalled lot which may compromise the sterility of the product. The recall status is terminated (terminated February 28, 2017). Affected quantity: 120 pouches.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2015
- Initiation Date
- February 26, 2015
- Termination Date
- February 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 pouches
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.
Reason for Recall
Leaks were detected in the recalled lot which may compromise the sterility of the product.
Distribution Pattern
Distributed to the states of CA, IL, MA, MI, MO, and WI.
Code Information
Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01