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FDA Recall Z-0203-2013 · Posted 2012-11-05
Recall StatusTerminated
Product CodeGES
Date Initiated2012-08-15
Date Terminated2014-01-13
Product Quantity117,948 units (total)
Reason for Recall
Potential for bent tips.
Firm Action
Angiotech sent an Urgent Product Recall Notification letter dated August 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the current inventory, segregate the affected lot numbers, and to return the identified product. Customers were asked to complete the attached Customer Acknowledgement Form and fax to the Quality Assurance department at 787-658-1073. If product was further distributed customers should notify their customers to whom they sold the affected product.
Customers with questions should call 787-658-1800 option 2 ext. 1775 or 787-658-1800 option 2 ext 1807.
For questions regarding this recall call 787-658-1800.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.