Recall Z-2152-2011 ยท CBL Absorbent, Carbon-Dioxide
Allied Healthcare Products Inc
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
| Date | May 6, 2011 (initiated Aug 12, 2010) |
| Status | Terminated |
| Reason | The granules do not absorb as long as expected in the anesthesia machines |
| 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 inst |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.