CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients.
FDA Recall Z-2242-2010 · Posted 2010-08-20
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Recalling FirmCivco Medical Instruments Inc
Recall StatusTerminated
Product CodeITX
Date Initiated2010-07-20
Date Terminated2012-04-13
Product Quantity22 boxes
Reason for Recall
Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover.
Firm Action
CIVCO sent a "Urgent - Medical Device Correctdion" letter date July 19, 2010 to consignees describing the reason for recall and requesting they dispose of the affect lot number of product. A response form was enclosed for completion and return to the firm, indicating the amount of product in inventory and requesting a Return Authorization Number. The form was to be returned via FAX or e-mail. Customers may contact CIVO at 800-445-6741.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide distribution: the states of OH, MD, NE, VA, IA, MI, WA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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