Reported Nov 20, 2013 · Terminated
Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is…
Applied Medical Resources Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Applied Medical Resources Corp · 22872 Avenida Empresa # 3 · Rancho Santa Margarita, CA · 92688-2650
Is this the product you have?
- 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.
- Lot codes and dates
- Model Number CD004
- Lot Nubmers
75 of 75 codes
116126811612691164934116835811683611169317116931811706941170700117070111712141172482117266411742871174793117485711751231175280117547211765551177023117787111790691179392117946011797751179890118029111804111180576118164711816481181649118193911827601182934118322511838231183957118427311847281184915118491611877791188817118911711899571190294119035811912081192057119296911931961193661119401011946661194807119551811957271195997
- Amount recalled
- 29,506 units
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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