FDA-Device2017-11-15Class II
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Windstone Medical Packaging, Inc.
Hazard
Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
Sold states
US Distribution to the state of : SC
Affected count
60 kits
Manufactured in
1602 4th Ave N, N/A, Billings, MT, United States
Products
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0069-2018Don't want to check this manually?
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