Recall Z-1330-2016— Applied Medical Resources Corp
Class II · Terminated
Class II FDA medical device recall by Applied Medical Resources Corp, initiated 2015-12-22, terminated 2016-10-03. FDA's recall record names no specific 510(k) clearance for this event. Product: STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.. Reason: Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance..
- Recalling firm
- Applied Medical Resources Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-22
- Terminated
- 2016-10-03
- Firm location
- Rancho Santa Margarita, CA, United States
Product description
STD GK258, AME Standard Kit 44 Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
Reason for recall
Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.