Recall Z-0561-2011 ยท CBL Absorbent, Carbon-Dioxide
Darex Container Products Div of W.R. Grace & Co.
Grace SODASORB LF Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorbent is depleted or upon moisture loss; Manufactured by: W.R. Grace & Co., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks pre-filled 2.5 lb. canisters, 12 per carton Sodasorb LF is used for absorption of carbon dioxide
| Date | Dec 8, 2010 (initiated Oct 20, 2010) |
| Status | Terminated |
| Reason | Pre-Pak units of SODASORB CO2 absorbent manufactured prior to August 2010 may have missing or illegible expiration dates and/or batch numbers. |
| Root cause | Packaging process control |
| Action | 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 expira |
| Quantity | 8,096 cartons |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.