BLUE BURN SHEET — Class II medical device recall Z-0233-2018
Terminated recall by Dukal Corp., reported 2017-12-20, distributed nationwide. Intact carton revealed presence of shredded burn sheets
| Recall number | Z-0233-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dukal Corp., Ronkonkoma, NY, United States |
| Recall initiated | 2017-06-01 |
| Classified | 2017-12-12 |
| Reported by FDA | 2017-12-20 |
| Terminated | 2018-07-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Lot numbers | JT00609, JT00811, JT00812, JT01614, JT04614, JT04809, JT05011, JT06814, JT07312, JT07911, JT09008, JT09113, JT11308, JT11511, JT11812, JT13607, JT13612, JT15209, JT15408, JT15911, JT17011, JT17507, JT17510, JT17513, JT17712, JT18209, JT18211, JT18408, JT18708, JT19209, JT21511, JT21812, JT22409, JT22709, JT23209, JT23408, JT23610, JT24010, JT24508, JT24713 and 23 more |
| Model numbers | 30-01, 7305 |
Product
BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection.
Reason for recall
Intact carton revealed presence of shredded burn sheets
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/Z-0233-2018. 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.