FDA Drug recall D-0229-2017
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into in…
- FDA Drug
- Class I
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class I recall of COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into in… by Sage Products, citing microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0229-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2016-07-29 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sage Products |
| Distribution | US |
Product
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
Reason
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Identifiers
| ndc | 53462-915-50 |
|---|---|
| ndc | 53462-915-51 |
| ndc | 53462-915-62 |
| ndc | 53462-915-80 |
| ndc | 53462-915-81 |
| ndc | 53462-915-24 |
| ndc | 53462-0915-62 |
| code_info | Lot #: a) 53957, Exp 03/06/18; b) 54769, Exp 04/22/18; 54922, Exp 05/03/18; 55781, Exp 06/19/18; c) 53095, Exp 07/13/17 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0229-2017%22
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