Device product

Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO

Z-1079-2024

December 22, 2023

Class I

Product summary

Firm: Windstone Medical Packaging, Inc.
Event: Event 93807
Status: Ongoing
Classification: Class I
Quantity: 1,528 units
Official record key: device-enforcement:Z-1079-2024

Official wording

Reason: Sterility assurance for saline included in surgical kits cannot be guaranteed.

Code information: DI: B098AMS108330/Lot #s: 173719 176590 174338 175529 176217 178271 178489 180907 183355 183674 184398 185064 188137 189007 189640 189641 189642 191067 192551 196380 197727 198046 198373 181439 194252 199297

Distribution pattern: US: FL, IL, CA OUS: None

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Sterility assurance for saline included in surgical kits cannot be guaranteed.