CIVCO Surgi-Tip Transducer Cover Sterile recall: Sterility Concern
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.
Why was CIVCO Surgi-Tip Transducer Cover Sterile recalled?
Leaks were detected in the recalled lot which may compromise the sterility of the product.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01
- 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.
- Recalling firm
- Civco Medical Instruments Inc
- Quantity
- 120 pouches
- Distribution
- Distributed to the states of CA, IL, MA, MI, MO, and WI.
- Recall date
- April 15, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)