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FDA device recall Z-0203-2013 · posted 2012-11-05 · Terminated

Recall details

Recalling firm

Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.

Reason for recall

Potential for bent tips.

Action taken

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

Status

Terminated

Product code

GES

Quantity affected

117,948 units (total)

Distribution

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, Ger

Date initiated

2012-08-15

Date posted

2012-11-05

Date terminated

2014-01-13

Location

Aguadilla, PR