Reported Apr 15, 2015 · Terminated
CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm)…
Civco Medical Instruments Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Civco Medical Instruments Inc · 102 1st St S · Kalona, IA · 52247-9589
Is this the product you have?
- 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.
- Lot codes and dates
Tyvek pouch - lot M591280Box lot - M612600 Expiration date 2018.01
- Amount recalled
- 120 pouches
Where it was sold
Why it was recalled
Leaks were detected in the recalled lot which may compromise the sterility of the product.
This product could cause temporary or reversible health problems — stop using it.
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