Recall Z-1247-2017— DeRoyal Industries Inc
Class III · Terminated
Class III FDA medical device recall by DeRoyal Industries Inc, initiated 2017-01-25, terminated 2022-01-13. It names one FDA 510(k) clearance: K842648. Product: DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.. Reason: 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..
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2017-01-25
- Terminated
- 2022-01-13
- Firm location
- Powell, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DeRoyal Heart Tracecart REF 53-1769, 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.