Allied Healthcare Products Inc. CarbO2Lime Carbon Dioxide Absorbent Granules for Canister Refill, Non-Hygroscopic Soda L

FDA device recall Z-2152-2011 · posted 2011-05-06 · Terminated

Recall details

Recalling firm

Allied Healthcare Products Inc

Reason for recall

The granules do not absorb as long as expected in the anesthesia machines

Action taken

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.

Root cause

Other

Status

Terminated

Product code

CBL

Quantity affected

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.

Date initiated

2010-08-12

Date posted

2011-05-06

Date terminated

2012-03-28

Location

Saint Louis, MO