Civco Medical Recalls Sterile Ultrasound Transducer Covers Due to Leaks
Civco Medical Instruments is recalling 120 sterile ultrasound transducer covers because leaks were detected that may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile medical device where leaks may compromise sterility, posing a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Civco Medical Instruments Inc is recalling 120 pouches of CIVCO Surgi-Tip Transducer Cover Sterile (REF 610-833). The product is a polyethylene telescopically-folded cover with an attached NeoGuard tip, packaged in Tyvek pouches with gel and fasteners. The recalled lot is M591280 (pouch) and M612600 (box), with an expiration date of 2018.01.
The recall was initiated because leaks were detected in the recalled lot, which may compromise the sterility of the product. The product is intended for use in scanning and needle-guided procedures for body surface, endocavity, and intra-operative diagnostic ultrasound.
The affected product was distributed to the states of California, Illinois, Massachusetts, Michigan, Missouri, and Wisconsin. Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- 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…
- Manufacturer
- Civco Medical Instruments Inc
- Affected units
- 120
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Tyvek pouch - lot M591280
- Box lot - M612600 Expiration date 2018.01
Distribution
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