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

FDA device recall Z-0850-05 · posted 2005-05-25 · Terminated

Recall details

Recalling firm

Darex Container Products Div of W.R. Grace & Co.

Reason for recall

Both lots were found to be out of specification due to an elevated level of small particles (fines).

Action taken

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.

Root cause

Other

Status

Terminated

Product code

CBL

Quantity affected

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

Date initiated

2005-03-31

Date posted

2005-05-25

Date terminated

2006-07-31

Location

Chicago, IL