International Manufacturing Solutions Operaciones
5 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (5)
Devices registered here (1)
- Fiber, Medical, AbsorbentProduct code FRL (opens in a new tab) · Class I · General Hospital · 21 CFR 880.5300
Recalls & enforcement
- Class IITerminated2019-05-08This product has been contaminated with Stenotrophomonas lactiubi.
- Class IITerminated2018-12-14The product is contaminated with Pseudomonas.
- Class IITerminated2018-03-21The products exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.
- Class IITerminated2017-11-03Affected lots may have exceeded its microbial limits.
- Class IITerminated2017-04-17Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “International Manufacturing Solutions Operaciones (FEI 3014644369) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014644369-international-manufacturing-solutions-op/
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