COMFORT SHIELD — Class I drug recall D-0229-2017
Terminated recall by Sage Products LLC, reported 2016-12-28, distributed nationwide. Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
| Recall number | D-0229-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sage Products LLC, Cary, IL, United States |
| Recall initiated | 2016-07-29 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2019-03-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BH, CA, DE, DK, GB, HN, IE, MX, MY, NL, PT, SA, SG, SV |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia |
| NDC | 53462-0915, 53462-0915-24, 53462-0915-50, 53462-0915-51, 53462-0915-62, 53462-0915-80, 53462-0915-81 |
| Expiration dates | 2017-07-13, 2018-03-06, 2018-04-22, 2018-05-03, 2018-06-19 |
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 for recall
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0229-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.