Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14)

FDA device recall Z-2533-2017 · posted 2017-06-14 · Terminated

Recall details

Recalling firm

Applied Medical Resources Corp

Reason for recall

Due to possibility of insufficient sterilization.

Action taken

An Urgent Medical Device Recall letter dated 5/4/17 was sent to customers to inform them that Applied Medical is conducting a voluntary recall of specific lots of Kii trocar models, CTB14 Kii 5x55mm Shielded Bladed Z-Thread Dual Pack and CTB23 Kii 5x55mm Low Profile Bladed Z-Thread Dual Pack, due to the possibility of insufficient sterilization. Customers are instructed to complete the attached recall notification confirmation form to acknowledge the recall and indicate if their facility is returning or already used the lots on recall. Customers are instructed to return the Recall Notification Confirmation Form to Applied Medical by emailing to recall60738625@appliedmedical.com or faxing to 949-713-8847. The recall letter instructs the customers that for product return questions to contact Karen Mitchell, Associate Manager Sales Operations, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com. For regulatory questions, please contact me, Lauren Contursi, at (949) 713-8767 or by email at contursi@appliedmedical.com. On 8/21/17 an Urgent Medical Device recall letter was sent to their customers to inform them that Applied Medical is conducting a voluntary recall of specific lots of the Kii trocar model, CTR14 Kii 5x55mm Optical Z-Thread Dual Pack. During shipment, the trocar packaging has the potential to become punctured with small holes, which would compromise the sterile barrier.

Root cause

Under Investigation by firm

Status

Terminated

Product code

GCJ

Quantity affected

7,939 units total (870 units in US)

Distribution

US and worldwide: Australia, Finland, France, United Kingdom

Date initiated

2017-05-04

Date posted

2017-06-14

Date terminated

2018-03-06

Location

Rancho Santa Margarita, CA

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