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

FDA device recall Z-0560-2011 · posted 2010-12-08 · Terminated

Recall details

Recalling firm

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

Reason for recall

Pre-Pak units of SODASORB CO2 absorbent manufactured prior to August 2010 may have missing or illegible expiration dates and/or batch numbers.

Action taken

Darex/W.R. Grace sent a Customer Notification to their sole direct account of the recall and the account provided Darex/W.R. Grace with lists of their customers who received the recalled products. Darex then sent undated recall letters to those accounts on 10/20-22/10. The accounts were informed of the product, the problem, and the action that should be taken. The accounts were warned not to use Pre-Pak units with missing or illegible expiration dates and/or batch numbers and were requested to examine their inventories of Pre-Pak units, placing all units that had missing or illegible expiration dates and/or batch numbers on hold for destruction and replacement. The accounts were instructed to call W.R. Grace at 1-800-492-7632 to arrange for replacement. The accounts were also requested to complete and return the reply postcard, indicating how much product was destroyed.

Root cause

Packaging process control

Status

Terminated

Product code

CBL

Quantity affected

95,542 cartons

Distribution

Nationwide Distribution

Date initiated

2010-10-20

Date posted

2010-12-08

Date terminated

2011-09-21

Location

Chicago, IL