Recall Z-0263-2015— Customed, Inc
Class I · Terminated
Class I FDA medical device recall by Customed, Inc, initiated 2014-10-08, terminated 2017-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.. Reason: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection..
- Recalling firm
- Customed, Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-10-08
- Terminated
- 2017-08-14
- Firm location
- Fajardo, PR, United States
Product description
Gown Surgical Fabric Reinforced XL, Catalog number 900-2568. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason for recall
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Data sourced from openFDA. This site is unofficial and independent of the FDA.