Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
Reported: April 20, 2016 Initiated: January 7, 2016 #Z-1401-2016
Product Description
Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK
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
- 60
- Distribution
- Distributed only in Puerto Rico.
- Location
- Fajardo, PR
Frequently Asked Questions
What product was recalled? ▼
Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK. Recalled by Customed, Inc. Units affected: 60.
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-1401-2016.
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