Recall Z-1400-2015— Civco Medical Instruments Inc
Class II · Terminated
Class II FDA medical device recall by Civco Medical Instruments Inc, initiated 2015-02-26, terminated 2017-02-28. It names one FDA 510(k) clearance: K013721. 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.. Reason: Leaks were detected in the recalled lot which may compromise the sterility of the product..
- Recalling firm
- Civco Medical Instruments Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-02-26
- Terminated
- 2017-02-28
- Firm location
- Kalona, IA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.