Device product

HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I

Z-2295-2024

May 15, 2024

Class II

Product summary

Firm: American Contract Systems Inc
Event: Event 94765
Status: Ongoing
Classification: Class II
Quantity: 36 units
Official record key: device-enforcement:Z-2295-2024

Official wording

Reason: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.

Code information: UDI-DI: 00191072203175 LOT#"s: 646231 927241

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.