Home › Wellspect AB › SimPro™ Set
SimPro™ Set
Wellspect AB · Model 5330800 · UDI-DI 07333387043494
10
510(k) clearances
399
Adverse events
7
Recalls
121
Facilities
Description
Single Use Urinary Catheter with water sachet and Accessories. Fem/Ped Nelaton 8" 08FR
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-19 | MEDLINE INDUSTRIES, LP - Northfield | Undeclared latex |
| 2023-10-19 | MEDLINE INDUSTRIES, LP - Northfield | Undeclared latex |
| 2023-10-19 | MEDLINE INDUSTRIES, LP - Northfield | Undeclared latex |
| 2011-06-02 | Teleflex Medical | Sterile integrity cannot be guaranteed. |
| 2011-06-02 | Teleflex Medical | Sterile integrity cannot be guaranteed. |
| 2003-04-30 | Medegen Medical Products, LLC | Finished products were not sterilized. |
| 2003-03-25 | C.R. Bard, Inc., Urological Division | There is a potential for package seals to be open after sterilization. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.