• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Allied Healthcare Products Inc. CarbO2Lime

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Allied Healthcare Products Inc. CarbO2Lime
see related information
Date Posted May 06, 2011
Recall Status1 Terminated on March 28, 2012
Recall Number Z-2152-2011
Recall Event ID 57044
Premarket Notification
510(K) Number
K811260 
Product Classification Absorbent, Carbon-Dioxide - Product Code CBL
Product Allied Healthcare Products Inc. CarbO2Lime Carbon Dioxide Absorbent Granules for Canister Refill, Non-Hygroscopic Soda Lime USP-NF, Type: High Moisture (12% to 19%), Granule Size: 4 to 10 Mesh (4.8-2.0mm), packaged in 5-gal. pails, #55-01-0003; prepacked canisters (12 canisters/case), #55-01-0005; and replacement bags (12 bags/case), #55-01-0006, RX. The label shows the product is Manufactured by Allied Healthcare Products Inc., St. Louis, MO. The product is a non-hygroscopic soda lime compound that is specially formulated to absorb carbon dioxide from the respiratory gas stream in anesthesia applications.
Code Information Lot numbers C06910, C12410, C13810, C14410, C15510, C16210, C16610, C16810, C17210, C17410, C17610, and C17910
Recalling Firm/
Manufacturer
Allied Healthcare Products Inc
1720 Sublette Ave
Saint Louis, Missouri 63110-1927
For Additional Information Contact Stephen Mundwiller
314-771-2400
Manufacturer Reason
for Recall
The granules do not absorb as long as expected in the anesthesia machines
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Allied Healthcare Product, Inc. issued recall letters dated August 10, 2011, via certified mail beginning 8/12/10 and/or via e-mail with a read receipt. Letters were issued for both distributors and end-use customers (such as medical facilities or pharmacies) explaining the reason for recall. Distributors were requested to conduct a subrecall using the enclosed customer letter for end users. A response form was included for both distributors and end users to complete to indicate the amount of product to be returned. The customer was instructed to contact the recalling firm for return instructions. For questions regarding this recall call 314-268-1661.
Quantity in Commerce 949 pails, 335/12-canister cases, and 706/12-refill bag cases
Distribution Worldwide Distribution - USA including AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MD, MS, NC, NE, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Canada and Grenada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBL and Original Applicant = ALLIED HEALTHCARE PRODUCTS, INC.
-
-