Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ven

FDA device recall Z-1125-2013 · posted 2013-04-16 · Terminated

Recall details

Recalling firm

Instrumentation Industries Inc

Reason for recall

Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.

Action taken

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. For questions regarding this recall call 412-854-1133.

Root cause

Error in labeling

Status

Terminated

Product code

BTL

Quantity affected

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, V

Date initiated

2012-09-07

Date posted

2013-04-16

Date terminated

2013-07-05

Location

Bethel Park, PA

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