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Terminated

Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

FDA Recall Z-1621-2016 · Posted 2016-05-06

Recall StatusTerminated
Product CodeFZP
Date Initiated2016-04-01
Date Terminated2017-02-07
Product Quantity559,274

Reason for Recall

Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.

Firm Action

Customer notification letters were sent on 04/01/16 via UPS. The notification requests that customers check their inventory for recalled products, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indicate if the facility is returing or has already used any of the products. If customers are a distributor it is requested that they notify any facilities to which have been distributed the affected product. Customers are asked to return the Recall Notification Confirmation Form to Applied Medical by emailing to [email protected] or faxing to (949) 713-8921. Customers are to return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical. For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at [email protected]. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

U.S. distribution to the following: IL, IN, WY, PA, CA, LA, MN, AZ, OH, OR, CT, WI, NC, AK, NE, MI, KS, FL, MN, TN, SC, MA, MD, KY, TX, GA, TX, NJ, MO, CO, MS, MT, ID, ME, VA, NY, UT, MI, AL, PR, NM, DE, OK, WA, DC, NH, AR Foreign distribution to the following; Australia, Spain, New Zealand, Italy, Israel, Estonia, United Arab Emirates, Germany, Netherlands, France, Kuwait, Korea, Qatar, Mexico, Switzerland, Austria, Bahrain, Lebanon, Brazil, Belgium, United Kingdom, Finland, Japan, Argentina, Ireland, Iran, Denmark, Norway, Colombia, Serbia, Uruguay, Sweden, Canada, Costa Rica, South Africa, Czech Republic, Chile, Finland, India, Thailand, Malaysia

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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