FDA Enforcement
Class I
Terminated
Angiography Pack, Catalog number 900-1488. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Recall: Z-0295-2015
·
Reported December 10, 2014
Enforcement
- Recall Number
- Z-0295-2015
- 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
Angiography Pack, Catalog number 900-1488. 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 140513091 140613610 140714183 140814654
Distribution
US Distribution to Florida, New York and Puerto Rico..
Quantity
70