Recall Z-1125-2013 ยท BTL Ventilator, Emergency, Powered (Resuscitator)
Instrumentation Industries Inc
Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstruction
| Date | Apr 16, 2013 (initiated Sep 7, 2012) |
| Status | Terminated |
| Reason | Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use. |
| Root cause | Error in labeling |
| Action | Instrumentation Industries, Inc. initiated a recall of this product on September 7, 2012 by sending a letter via priority mail to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were instructed to replace the package insert of any affected product with the enclosed corrected package insert (now at Rev. H). The Directions for Use can alsbe downloaded from their website if they should need additional copies. If the product was further distributed consignees were asked to notify their consignees about this Field Correction |
| Quantity | 2998 |
| Distribution | Worldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. Shipped internationally to Canada, Ireland, Hong Kong, the Netherlands, New Zeala |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991785 | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR Instrumentation Industries, Inc., Aug 17, 1999 |