PlainRecalls
FDA Devices Moderate Class II Ongoing

DELIVERY PACK , Model No SGDV22D-01 SGDV22E

Reported: March 26, 2025 Initiated: February 6, 2025 #Z-1348-2025

Product Description

DELIVERY PACK , Model No SGDV22D-01 SGDV22E

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

Units Affected
36 kits
Distribution
US Nationwide distribution in the state of OH.
Location
Tiffin, OH

Frequently Asked Questions

What product was recalled?
DELIVERY PACK , Model No SGDV22D-01 SGDV22E. Recalled by American Contract Systems Inc. Units affected: 36 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-1348-2025.