Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0850-05

Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which...

Darex Container Products Div of W.R. Grace & Co. / initiated 2005-03-31 / Terminated

Darex Container Products Div of W.R. Grace & Co. began a recall of Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is... on . The reason FDA records is "Both lots were found to be out of specification due to an elevated level of small particles (fines)". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0850-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Darex Container Products Div of W.R. Grace & Co.
Product
Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; Manufactured by: W.R. Grace & Co. - Conn., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton) and 5-gallon pails
Product code
CBL Absorbent, Carbon-Dioxide
Reason for recall
Both lots were found to be out of specification due to an elevated level of small particles (fines).
FDA root cause
Other
Action
Recall letters dated 3/30/05 were sent to the accounts via DHL on 3/31/05, informing them that the two lots did not undergo final QC testing prior to shipment and do not meet finished product specifications. The accounts were requested to check their inventory for the affected lots, discontinue use and place it on hold pending return to W.R. Grace for replacement. Any questions were directed to the Sodasorb Recall Coordinator at 1-877-327-3987.
Quantity in commerce
360 PrePaks and 18 5-gallon pails
Distribution
California, Connecticut, Pennsylvania, Maine, Massachusetts, MIssissippi, New Hampshire, New Jersey, New York, Vermont, Virginia and West Virginia
Product codes and lots
pre-paks lot CR10-P115-14, exp. 10/2006, and 5-gallon pail lot CR09-P115-30, exp. 9/2006