Recall Z-1483-2016— Customed, Inc
Class II · Terminated
Class II FDA medical device recall by Customed, Inc, initiated 2016-01-07, terminated 2017-05-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.. Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile..
- Recalling firm
- Customed, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-07
- Terminated
- 2017-05-03
- Firm location
- Fajardo, PR, United States
Product description
Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason for recall
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Data sourced from openFDA. This site is unofficial and independent of the FDA.