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MTG
HR PHARMACEUTICALS INC. · Model 32112SP · UDI-DI 00850058254258
KOD
Prescription
10
510(k) clearances
17,205
Adverse events (30 deaths)
108
Recalls
111
Facilities
Description
12fr 16" Closed System Catheter Kit, Sample port 1500ml collection bag, std size BZK swabs
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-25 | C.R. Bard Inc | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| 2025-06-03 | C.R. Bard Inc | Cather packaging may contain the incorrect French size. |
| 2025-06-03 | C.R. Bard Inc | Cather packaging may contain the incorrect French size. |
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2022-09-20 | TELEFLEX LLC | Product may not be sterile |
| 2022-01-27 | C.R. Bard Inc | There is a potential to leak from the catheter where it connects to the drain bag |
| 2022-01-27 | C.R. Bard Inc | There is a potential to leak from the catheter where it connects to the drain bag |
| 2021-01-11 | C.R. Bard, Inc. | The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. |
| 2020-04-30 | Covidien Llc | Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead |
| 2020-04-30 | Covidien Llc | Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.