FDA-Device2024-02-07Class II
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
American Contract Systems, Inc.
Hazard
During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.
Sold states
US Nationwide distribution.
Affected count
144 units
Manufactured in
7802 E Telecom Pkwy, Temple Terrace, FL, United States
Products
Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0831-2024Don't want to check this manually?
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