Device Recall Atrapro Antipruritic Hydrogel, 1.5 oz gel tube 의 리콜

Recall

64316

Class 2

Z-0890-2013

2013-02-12

2013-02-26

Terminated

United States

2013-11-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115812

Out of specification result - stability test failure of free available chlorine (fac) which functions as a preservative for the hydrogel. the 13 month test result obtained was 4 ppm fac and the stability specification is >10 ppm fac.

Oculus sent an Urgent Medical Device Recall letter dated February 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue distribution and segregate the affected product. Immediately remove the affected lots of Recall product from the inventory of sales representative, sub contracted distribution and or fulfillment centers. Segregate the affected product in a secure location for return or destruction. If the product was further distributed customers were instructed to notify healthcare professionals of this recall. Customers were also instructed to completed and return the Business Reply Card and fax to 1-415-462-5163. Once the firm receives the affected product the customer would be contacted by an Oculus Representative and provided a Returns Goods Authorization (RGA) number. For questions customers were instructed to call 1-707-559-2445. For questions regarding this recall 707-559-7191, ext 14.