SRHS DeRoyal Heart Tracecart REF 53-1913 — Class III medical device recall Z-1248-2017
Terminated recall by DeRoyal Industries Inc, reported 2017-03-01, distributed in LA, MS. DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which
| Recall number | Z-1248-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2017-01-25 |
| Classified | 2017-02-23 |
| Reported by FDA | 2017-03-01 |
| Terminated | 2022-01-13 |
| Distributed | LA, MS |
| Quantity | 1,157 units |
| Reason classes | sterility |
| Lot numbers | 27273826, 27324507, 27388691, 27453704, 27567701, 27760202, 27784829, 27883843, 27883851, 27915382, 27970710, 28013209, 28103933, 28117702, 28158889, 28158897, 28373571, 28506329, 28550670, 28678471, 28736415, 28793591, 28854235, 28908619, 28929145, 29015901, 29083680, 29169619, 29206205, 29271816, 29468459, 29522443, 29577604, 29631367, 29694350, 29754130, 29799557, 29850826, 29914025, 29914130 and 226 more |
| Model numbers | 53-1913 |
Product
SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.
Reason for recall
DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage product which was subsequently recalled due to the current packaging configuration of the Atrium Ocean, Oasis, Express and Express Mini chest drainage products.
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-1248-2017. 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.