Recall Z-0233-2018— Dukal Corp.
Class II · Terminated
Class II FDA medical device recall by Dukal Corp., initiated 2017-06-01, terminated 2018-07-19. FDA's recall record names no specific 510(k) clearance for this event. 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: Intact carton revealed presence of shredded burn sheets.
- Recalling firm
- Dukal Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-01
- Terminated
- 2018-07-19
- Firm location
- Ronkonkoma, NY, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.