Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2152-2011

Allied Healthcare Products Inc. CarbO2Lime Carbon Dioxide Absorbent Granules for Canister Refill...

Allied Medical LLC / initiated 2010-08-12 / Terminated

Allied Healthcare Products Inc began a recall of Allied Healthcare Products Inc. CarbO2Lime Carbon Dioxide Absorbent Granules for Canister Refill, Non-Hygroscopic Soda Lime USP-NF, Type: High Moisture (12% to... on . The reason FDA records is "The granules do not absorb as long as expected in the anesthesia machines". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2152-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Allied Medical LLC
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.
Product code
CBL Absorbent, Carbon-Dioxide
Reason for recall
The granules do not absorb as long as expected in the anesthesia machines
FDA root cause
Other
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.
Product codes and lots
Lot numbers C06910, C12410, C13810, C14410, C15510, C16210, C16610, C16810, C17210, C17410, C17610, and C17910