Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified

FDA device recall Z-0183-2014 · posted 2014-01-24 · Terminated

Recall details

Recalling firm

Applied Medical Resources Corp

Reason for recall

Applied Medical is conducting a voluntary recall of the Inzii 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The likelihood of this situation to occur and result in patient harm is highly unlikely; however, out of an abundance of caution for patient safety and a commitmen

Action taken

Customer notifications of the recall began the week of 10/21/2013 via UPS overnight with letters requesting that all affected products be returned to Applied. The notification letter is dated October 21, 2013 and titled "URGENT: MEDICAL DEVICE RECALL". The notification was accompanied by a Recall Notification Confirmation Form. The letter informed customers of the recall by providing the product description with codes (Model and Lot Numbers). reason for the recall, actions to take and contact information.

Root cause

Package design/selection

Status

Terminated

Product code

GCJ

Quantity affected

29,506 units

Distribution

Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, India, Ir

Date initiated

2013-10-21

Date posted

2014-01-24

Date terminated

2014-09-15

Location

Rancho Santa Margarita, CA

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