Z-0183-2014Class II

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

Name: Z-0183-2014 Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is...
Creator: Applied Medical Resources Corp
Published: 2013-10-21
License: https://open.fda.gov/license/

Applied Medical Resources Corp / initiated 2013-10-21 / Terminated / root cause: packaging

FDA source

Applied Medical Resources Corp began a recall of Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared... on 2013-10-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0183-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-21
Posted: 2014-01-24
Terminated: 2014-09-15
Recalling firm: Applied Medical Resources Corp
Product: Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.
Product code: GCJ Laparoscope, General & Plastic Surgery
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
Root cause tag: packaging
FDA root cause: Package design/selection
Action: 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.
Quantity in commerce: 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, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, New Zealand, Netherlands, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, United Arab Emirates, and United Kingdom.
Product codes and lots: Model Number CD004. Lot Nubmers: 1161268, 1161269, 1164934, 1168358, 1168361, 1169317, 1169318, 1170694, 1170700, 1170701, 1171214, 1172482, 1172664, 1174287, 1174793, 1174857, 1175123, 1175280, 1175472, 1176555, 1177023, 1177871, 1179069, 1179392, 1179460, 1179775, 1179890, 1180291, 1180411, 1180576, 1181647, 1181648, 1181649, 1181939, 1182760, 1182934, 1183225, 1183823, 1183957, 1184273, 1184728, 1184915, 1184916, 1187779, 1188817, 1189117, 1189957, 1190294, 1190358, 1191208, 1192057, 1192969, 1193196, 1193661, 1194010, 1194666, 1194807, 1195518, 1195727, 1195997, 1197182, 1197404, 1197832, 1198055, 1198968, 1199899, 1200658, 1200828, 1200829, 1200830, 1201739, 1201740, 1201741, 1203154, 1204054.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0183-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0183-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-08

Product code GCJ

K060051Class IISpecimen Retrieval SystemApplied Medical Resources Corp. / cleared 2006-01-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)