Civco Medical Instruments Inc: Medical Device Recall in 2015 - (Recall #: Z-1400-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 26, 2015

Date Posted: April 15, 2015

Recall Number: Z-1400-2015

Event ID: 70719

Reason for Recall:

Leaks were detected in the recalled lot which may compromise the sterility of the product.

Status: Terminated

Product Quantity: 120 pouches

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.

Voluntary or Mandated:

Voluntary: Firm initiated