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U.S. Department of Health and Human Services

Class 2 Device Recall SODASORB 48 IND H MED PrePaks

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  Class 2 Device Recall SODASORB 48 IND H MED PrePaks see related information
Date Initiated by Firm October 20, 2010
Date Posted December 08, 2010
Recall Status1 Terminated 3 on September 21, 2011
Recall Number Z-0560-2011
Recall Event ID 57064
Product Classification Absorbent, carbon dioxide - Product Code CBL
Product SODASORB 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; 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
The indicator soda lime product is used for absorption of carbon dioxide in anesthesia rebreathing systems and respiratory therapy equipment with oxygen, nitrous oxide, halothane, enflurane, sevoflurane, desflurane and isoflurane.
Code Information Batch Numbers: CW10-P115-01, CW10-P115-02, CW10-P115-11, CW10-P115-12, CW10-P115-13, CW10-P115-17, CW10-P115-18, CW10-P115-21, CW10-P115-22, CW10-P115-23, CW10-P115-26, CW10-P115-27, CW10-P115-30, CW10-P115-32, CW10-P115-33, CW11-P115-01, CW11-P115-02, CW11-P115-03, CW11-P115-04, CW11-P115-05, CW11-P115-06, CW11-P115-07, CW11-P115-09, CW11-P115-11, CW11-P115-12, CW11-P115-13, CW11-P115-20, CW12-P115-03, CW12-P115-04, CW12-P115-05, CW12-P115-06, CW12-P115-07, CW12-P115-08, CW12-P115-10, CW12-P115-12, CX01-P115-01, CX01-P115-02, CX01-P115-03, CX01-P115-09, CX01-P115-10, CX01-P115-11, CX01-P115-14, CX01-P115-15, CX02-P115-05, CX02-P115-05, CX02-P115-06, CX02-P115-08, CX02-P115-09, CX02-P115-10, CX02-P115-11, CX02-P115-12, CX02-P115-13, CX03-P115-04, CX03-P115-05, CX03-P115-06, CX03-P115-07, CX03-P115-08, CX03-P115-09, CX03-P115-10, CX03-P115-12, CX03-P115-21, CX03-P115-22, CX03-P115-23, CX03-P115-26, CX03-P115-27, CX03-P115-28, CX03-P115-32, CX04-P115-01, CX04-P115-02, CX04-P115-05, CX04-P115-06, CX04-P115-07, CX04-P115-08, CX04-P115-09, CX04-P115-12, CX04-P115-13, CX04-P115-16, CX04-P115-17, CX04-P115-17, CX04-P115-19, CX04-P115-22, CX05-P115-05, CX05-P115-05, CX05-P115-06, CX05-P115-08, CX05-P115-10, CX05-P115-15, CX05-P115-16, CX05-P115-17, CX06-P115-03, CX06-P115-06, CX06-P115-07, CX06-P115-09, CX06-P115-10, CX06-P115-11, CX06-P115-12, CX06-P115-14, CX06-P115-15, CX06-P115-22, CX06-P115-23, CX06-P115-28, CX06-P115-29, CX07-P115-15, CX07-P115-16, CX07-P115-17, CX07-P115-20, CX07-P115-22, CX08-P115-04, CX08-P115-04, CX08-P115-05, CX08-P115-06, CX08-P115-10, CX09-P115-01, CX09-P115-02, CX09-P115-06, CX09-P115-07, CX09-P115-09, CX09-P115-10, CX09-P115-11, CX09-P115-18, CX09-P115-18, CX09-P115-19, CX09-P115-20, CX09-P115-21, CX09-P115-22, CX09-P115-23, CX09-P115-29, CX09-P115-29, CX09-P115-31, CX11-P115-01, CX11-P115-03, CX11-P115-06, CX11-P115-07, CX11-P115-09, CX11-P115-09, CX11-P115-09, CX12-P115-01, CX12-P115-01, CX12-P115-02, CX12-P115-02, CX12-P115-03, CX12-P115-04, CX12-P115-05, CX12-P115-06, CX12-P115-07, CX12-P115-08, CZ01-P115-01,CZ01-P115-02, CZ01-P115-03, CZ01-P115-04, CZ01-P115-06, CZ01-P115-07, CZ01-P115-08, CZ01-P115-08, CZ01-P115-11, CZ01-P115-11, CZ01-P115-12, CZ01-P115-13, CZ01-P115-14, CZ01-P115-14, CZ01-P115-18, CZ01-P115-19, CZ01-P115-20, CZ01-P115-21, CZ01-P115-22, CZ01-P115-23, CZ01-P115-24, CZ02-P115-07, CZ02-P115-11, CZ02-P115-11, CZ02-P115-13, CZ02-P115-14, CZ02-P115-15, CZ02-P115-16, CZ02-P115-18, CZ02-P115-19, CZ02-P115-21, CZ02-P115-22, CZ03-P115-08, CZ03-P115-08, CZ03-P115-08, CZ03-P115-08, CZ03-P115-08, CZ03-P115-10, CZ03-P115-11, CZ03-P115-12, CZ03-P115-13, CZ03-P115-13, CZ03-P115-14, CZ03-P115-15, CZ04-P115-01, CZ04-P115-02, CZ04-P115-03, CZ04-P115-04, CZ04-P115-05, CZ04-P115-08, CZ04-P115-09, CZ04-P115-10, CZ05-P115-02, CZ05-P115-03, CZ05-P115-04, CZ05-P115-05, CZ05-P115-07, CZ05-P115-08, CZ05-P115-09, CZ05-P115-10, CZ05-P115-11, CZ05-P115-15, CZ05-P115-16, CZ05-P115-17, CZ05-P115-18, CZ05-P115-19, CZ05-P115-20, CZ05-P115-21, CZ05-P115-22, CZ05-P115-23, CZ05-P115-24, CZ05-P115-25, CZ05-P115-26, CZ05-P115-27, CZ05-P115-28, CZ05-P115-32, CZ05-P115-33, CZ07-P115-06, CZ07-P115-07, CZ07-P115-08, CZ07-P115-11, CZ07-P115-13, CZ07-P115-14, CZ07-P115-15, CZ07-P115-17, CZ07-P115-20, CZ07-P115-21, CZ08-P115-01, CZ08-P115-02, CZ08-P115-09, CZ08-P115-10,  
Recalling Firm/
Manufacturer		 Darex Container Products Div of W.R. Grace & Co.
6050 W 51st St
Chicago IL 60638-1405
For Additional Information Contact Ms. Stephanie A. Wood
617-498-4357
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 95,542 cartons
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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