Theragenics Costa Rica Limitada
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (3)
- Wire, Guide, CatheterProduct code DQX (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1330
- Stylet, CatheterProduct code DRB (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1380
- Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassProduct code DTL (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4290
Recalls & enforcement
- Class IITerminated2018-10-09Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
Related
- All facilities operated by Theragenics Corporation
- THERAGENICS CORP. (GA)
- GALT MEDICAL CORP. (TX)
- Theragenics Costa Rica Limitada (CR)
- NeedleTech Products, Inc. (MA)
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. “Theragenics Costa Rica Limitada (FEI 3036802499) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3036802499-theragenics-costa-rica-limitada/
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