Recall Z-0945-2015— Centurion Medical Products Corporation
Class II · Terminated
Class II FDA medical device recall by Centurion Medical Products Corporation, initiated 2014-10-23, terminated 2015-06-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit). Reason: According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper..
- Recalling firm
- Centurion Medical Products Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-23
- Terminated
- 2015-06-08
- Firm location
- Williamston, MI, United States
Product description
Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit)
Reason for recall
According to the recall notice received from Hospira, the recall was initiated due to a confirmed customer report of particulate in a single unit. Hospira identified the particulate as human hair, embedded in and attached to a pinched area of the stopper.
Data sourced from openFDA. This site is unofficial and independent of the FDA.