DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Reported: September 9, 2015 Initiated: July 10, 2015 #Z-2593-2015
Product Description
DRESSING CHANGE CUSTOMED 50/CS 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.
Details
- Recalling Firm
- Customed, Inc
- Units Affected
- 1050
- Distribution
- Distributed Only in Puerto Rico.
- Location
- Fajardo, PR
Frequently Asked Questions
What product was recalled? ▼
DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .. Recalled by Customed, Inc. Units affected: 1050.
Why was this product recalled? ▼
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 9, 2015. Severity: Moderate. Recall number: Z-2593-2015.
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