Epix Universal Clip Applier, REF: CA500, STERILEEO
Recall
- Recall Number
- Z-1388-2024
- Event Number
- 94034
- Firm
- Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa
- FEI Number
- 2027111
- Product Code
- MDM
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- January 30, 2024
- Posted
- March 27, 2024
- Address
- Margarita, CA, 92688-2650
Description
Epix Universal Clip Applier, REF: CA500, STERILEEO
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
On February 16, 2024, Applied Medical issued a "Urgent: Medical Device Recall" notification to affected consignees via UPS. In addition, to informing consignees about the recall, Applied Medical asked consignees to take the following actions: " Check your inventory for recalled product. " Quarantine any product from the impacted lots above (Page 1) or kits listed below (Page 7-10). " Complete the attached Distributor Recall Notification Confirmation Form (Page 4) to acknowledge the recall and indicate if your facility is returning or has already used the lots listed above. o If no product is being returned, please indicate on the Distributor Recall Notification Confirmation Form (Page 4). o Please notify any facilities to which you distributed the affected product with a copy of this notification. Please also complete the Distributor Recall Notification Confirmation Report (Page 5). o For any product returned to your facility, please return the affected product to Applied Medical. " Return the Recall Notification Confirmation Form to Applied Medical by emailing to [email protected] or faxing to (949) 221-3639. " Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical (Product Return Instructions are on Page 6).
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Romania, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Venezuela.