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.
FDA Recall Z-1400-2015 · Posted 2015-04-08
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Recalling FirmCivco Medical Instruments Inc
Recall StatusTerminated
Product CodeITX
Date Initiated2015-02-26
Date Terminated2017-02-28
Product Quantity120 pouches
Reason for Recall
Leaks were detected in the recalled lot which may compromise the sterility of the product.
Firm Action
On 3/12/2015, the Urgent Medical Device Recall notice was emailed to all of the affected customers. The notice identified the affected product and stated that the sterile covers from the affected manufacturing lot were not meeting quality levels and may leak. Customers were requested to return all of surgi tip covers from the production lot identified for replacement. To schedule the return and arrange for replacement product to be sent, customers were asked to contact Ms. Amy King, Customer Service Team Leader at 319-248-6520 or [email protected].
Root Cause
Process design
Distribution Pattern
Distributed to the states of CA, IL, MA, MI, MO, 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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