LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Reported: March 26, 2025 Initiated: February 6, 2025 #Z-1352-2025
Product Description
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Reason for Recall
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Details
- Recalling Firm
- American Contract Systems Inc
- Units Affected
- 237 kits
- Distribution
- US Nationwide distribution in the state of OH.
- Location
- Tiffin, OH
Frequently Asked Questions
What product was recalled? ▼
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B. Recalled by American Contract Systems Inc. Units affected: 237 kits.
Why was this product recalled? ▼
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1352-2025.
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