Sterile Custom Packs to be used in surgical procedures.
Reported: June 10, 2020 Initiated: April 13, 2020 #Z-2171-2020
Product Description
Sterile Custom Packs to be used in surgical procedures.
Reason for Recall
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Details
- Recalling Firm
- American Contract Systems
- Units Affected
- 2868 total kits
- Distribution
- US Nationwide distribution including in the state of Pennsylvania.
- Location
- Zelienople, PA
Frequently Asked Questions
What product was recalled? ▼
Sterile Custom Packs to be used in surgical procedures.. Recalled by American Contract Systems. Units affected: 2868 total kits.
Why was this product recalled? ▼
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2171-2020.
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