Darex Container Products Div of W.R. Grace & Co.
Chicago, IL
Darex Container Products Div of W.R. Grace & Co. appears in FDA device records in Chicago, IL. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 5 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 5
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0561-2011 | 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 in low flow anesthesia rebreathing systems and respiratory therapy equipment with oxygen, nitrous oxide, halothane, enflurane, desflurane, sevoflurane and isoflurane. | Pre-Pak units of SODASORB CO2 absorbent manufactured prior to August 2010 may have missing or illegible expiration dates and/or batch numbers. | Terminated | ||
| Z-0560-2011 | 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. | Pre-Pak units of SODASORB CO2 absorbent manufactured prior to August 2010 may have missing or illegible expiration dates and/or batch numbers. | Terminated | ||
| Z-0850-05 | 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 | Both lots were found to be out of specification due to an elevated level of small particles (fines). | Terminated | ||
| Z-0730-03 | High Performance Sodasorb Carbon Dioxide Absorbent, Diving Grade(18%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; Manufactured by: W.R. Grace & Company, 6050 West 51st Street, Chicago, IL 60638; the product is packaged in 5-gallon pails under the W.R. Grace label | Contaminated with epoxy chips. | Terminated | ||
| Z-0731-03 | 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 & Company, 6050 West 51st Street, Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton), canister paks (pre-measured 2.5 lb. bags, 12 per carton), 5-gallon pails and 55-gallon drums under the W.R. Grace label and the Portex label distributed by Sims Portex Inc., Keene, NH 03431 | Contaminated with epoxy chips. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain