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
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