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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only 6) REF 28-0212H Heated Hi-Flow Insufflation Tubing Rx Only. Used during laparoscopic surgical procedures to aid in the insufflation of the abdomen.
Recall Number Z-2113-2013
Classification Class II
Code Info All Lots of the Insufflation Tubing Sets are as follows: REF 28-0206 Insufflation Tubing, Laparoscopic, Lot #29074214; REF 28-0214 Hi-Flow Insufflation Tubing Lot #3194170; REF 28-0216 Tubing, Insuf w/.3 Micr Filter Lot #29074249; REF 28-0217 Insufflation Tubing, Laparoscopic Lot #32305010; DeRoyal REF 28-0208 Insufflation Tubing w/Vent Lot #29314302; DeRoyal REF 28-0212H Heated Hi-Flow Insufflation Tubing Lot #29000354.
Product Distributed Qty 506,632 sets in US; 17,854 sets International
Reason For Recall DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device.

Event Detail

Event Id 65764
Product Type Devices
Status Ongoing
Recalling Firm DeRoyal Industries Inc
City Powell
State TN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-15
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and the countries of Dubai, Arab Emirates, Quebec, Canada, Japan, and Ireland.
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