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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Civco Medical Instruments Inc
- Reason for Recall:
- Leaks were detected in the recalled lot which may compromise the sterility of the product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
Tyvek pouch - lot M591280; Box lot - M612600 Expiration date 2018.01
Distribution:
Distributed in: CA, IL, MA, MI, MO, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1400-2015
Related Recalls
A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.