Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reported: December 10, 2014 Initiated: October 8, 2014 #Z-0348-2015
Product Description
Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason for Recall
Significant 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.
Details
- Recalling Firm
- Customed, Inc
- Units Affected
- 944
- Distribution
- US Distribution to Florida, New York and Puerto Rico..
- Location
- Fajardo, PR
Frequently Asked Questions
What product was recalled? ▼
Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.. Recalled by Customed, Inc. Units affected: 944.
Why was this product recalled? ▼
Significant 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2014. Severity: Critical. Recall number: Z-0348-2015.
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