Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit

FDA device recall Z-1389-2024 · posted 2024-03-27 · Open, Classified

Recall details

Recalling firm

Applied Medical Resources Corp

Reason for recall

Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.

Action taken

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 recall60884853@appliedmedical.com 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).

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MDM

Quantity affected

17,990 units

Distribution

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

Date initiated

2024-01-30

Date posted

2024-03-27

Location

Rancho Santa Margarita, CA