FDA Enforcement
Class I
Terminated
Wound Management Tray, Catalog number 900-1154. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Recall: Z-0251-2015
·
Reported December 10, 2014
Enforcement
- Recall Number
- Z-0251-2015
- Event ID
- 69448
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Customed, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 10, 2014
- Initiation Date
- October 8, 2014
- Classification Date
- November 28, 2014
- Termination Date
- August 14, 2017
- Address
- Calle Igualdad Final #7, N/A, Fajardo, PR, 00738, United States
Description
Wound Management Tray, Catalog number 900-1154. 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.
Code Info
Lot numbers: 111112986 111123441 112010278 112041183 112051733 112062333 112093745 112104134 113026216 113047151 113068038 113078678 131110157 140111110 140312050 140513069 140814630 1130154790
Distribution
US Distribution to Florida, New York and Puerto Rico..
Quantity
27024