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SpeediCath Compact Set
Coloplast A/S · Model 28522 · UDI-DI 05708932967136
GBM
Prescription
10
510(k) clearances
2,608
Adverse events (4 deaths)
18
Recalls
79
Facilities
Description
SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Ready to use coated catheter. Nelaton. Female. Length: 3.5 in, Vol 750 ml. FR 12/4.0 mm. Rx only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-14 | Hollister Ulc | Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary |
| 2025-11-29 | HANGZHOU BEVER MEDICAL DEVICES CO., LTD. | Labeling error, Incorrect expiration date |
| 2023-12-04 | Cardinal Health 200, LLC | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. |
| 2021-08-05 | C.R. Bard Inc | There is potential for packaging defects that may impact the sterile barrier. |
| 2018-03-15 | Teleflex Medical Europe Ltd | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause All |
| 2011-04-21 | Coloplast Manufacturing US, LLC | Coloplast has initiated a recall on SpeediCath with Insertion Supplies and SureCath Set with Insertion Supplies because they contain Iodine prep pads which may expire before the ov |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis |
| 2008-07-17 | Apogee Medical, Inc | Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromis |
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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.