Catalog Number: 900996 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reported: April 20, 2016 Initiated: January 7, 2016 #Z-1494-2016
Product Description
Catalog Number: 900996 LAPAROTOMY SURGICAL PACK 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
- 111
- Distribution
- Distributed only in Puerto Rico.
- Location
- Fajardo, PR
Frequently Asked Questions
What product was recalled? ▼
Catalog Number: 900996 LAPAROTOMY SURGICAL PACK 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: 111.
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 April 20, 2016. Severity: Moderate. Recall number: Z-1494-2016.
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