Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN. Used for temporary internal drainage from the ureteropelvic junction to the bladder.
FDA Recall Z-0852-2011 · Posted 2011-01-05
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Recalling FirmVance Products Incorporated
Recall StatusTerminated
Product CodeFAD
Date Initiated2010-10-18
Date Terminated2011-07-27
Product Quantity25 units
Reason for Recall
The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong.
Firm Action
The firm sent URGENT: RECALL NOTICES dated 10/18/2010 to its direct accounts. The notice identified the affected product and instructed firms to pull the recalled product from stock and isolate it. Customers are to complete the form and e-mail or fax the form back to Cook. Product should be returned to the recalling firm using the Return Goods Authorization number. Cook Urological will credit customer accounts upon receipt of the returned product.
Root Cause
Packaging
Distribution Pattern
Worldwide Distribution -- USA, including states of WI, TX, NY, SC, AZ, TN, FL, AR, CA, AL, and WA and country of Canada.
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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